Trial Outcomes & Findings for Intravenous Dexmedetomidine for Cesarean Section (NCT NCT03065530)
NCT ID: NCT03065530
Last Updated: 2020-01-13
Results Overview
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
6h after cesarean section.
Results posted on
2020-01-13
Participant Flow
Parturients (\>18 and \<45 years old) with a singleton pregnancy admitted to our institute who underwent elective caesarean delivery under epidural anaesthesia were recruited in this study between February 2017 and October 2017.
not meeting inclusion criteria (n=39) declined to participate , n=14 other reasons, n=3
Participant milestones
| Measure |
Group C
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
29
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group C
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Intravenous Dexmedetomidine for Cesarean Section
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Dexmedetomidine 0.03ug/kg/h
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Dexmedetomidine 0.05ug/kg/h
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Dexmedetomidine 0.08ug/kg/h
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
31.75 years
STANDARD_DEVIATION 3.46 • n=93 Participants
|
31.41 years
STANDARD_DEVIATION 3.69 • n=4 Participants
|
32.07 years
STANDARD_DEVIATION 4.2 • n=27 Participants
|
31.11 years
STANDARD_DEVIATION 3.37 • n=483 Participants
|
31.59 years
STANDARD_DEVIATION 3.67 • n=36 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
China
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
114 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 6h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
|
3.143 units on a scale
Standard Deviation 1.38
|
2.897 units on a scale
Standard Deviation 1.012
|
1.665 units on a scale
Standard Deviation 1.045
|
1.25 units on a scale
Standard Deviation 0.7515
|
SECONDARY outcome
Timeframe: 48h after cesarean section.Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1).
Outcome measures
| Measure |
Group C
n=16 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=15 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=17 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Relative Infant Dose (RID) of Dexmedetomidine
|
0.1712 percentage of one hundred
Standard Deviation 0.1764
|
0.1967 percentage of one hundred
Standard Deviation 0.1141
|
0.3701 percentage of one hundred
Standard Deviation 0.2357
|
—
|
SECONDARY outcome
Timeframe: 12h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
|
3.29 score on a scale
Standard Deviation 1.01
|
2.86 score on a scale
Standard Deviation 0.99
|
1.62 score on a scale
Standard Deviation 0.78
|
0.93 score on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 6h after cesarean section.Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Ramsay Sedation Score(RSS)
|
2 score on a scale
Standard Deviation 0
|
2.17 score on a scale
Standard Deviation 0.38
|
2.14 score on a scale
Standard Deviation 0.35
|
3.14 score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 48h after cesarean section.The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
The Degree of Satisfaction
|
12 Participants
|
16 Participants
|
26 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 48h after cesarean section.Total times during 48h after cesarean section.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Number of Participants That Experienced Nausea or Vomiting
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12h after cesarean section.Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Ramsay Sedation Score(RSS)
|
2 score on a scale
Standard Deviation 0
|
2.21 score on a scale
Standard Deviation 0.41
|
2.28 score on a scale
Standard Deviation 0.45
|
3.21 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 24h after cesarean section.Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Ramsay Sedation Score(RSS)
|
2 score on a scale
Standard Deviation 0
|
2.07 score on a scale
Standard Deviation 0.26
|
2.10 score on a scale
Standard Deviation 0.31
|
2.25 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 48h after cesarean section.Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Ramsay Sedation Score(RSS)
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
|
3.21 score on a scale
Standard Deviation 0.92
|
2.93 score on a scale
Standard Deviation 1.03
|
1.72 score on a scale
Standard Deviation 0.84
|
1.57 score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 48h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS)
|
2.11 score on a scale
Standard Deviation 0.96
|
2 score on a scale
Standard Deviation 0.8
|
1.72 score on a scale
Standard Deviation 0.84
|
125 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
|
4.39 score on a scale
Standard Deviation 0.74
|
4.31 score on a scale
Standard Deviation 1.14
|
2.86 score on a scale
Standard Deviation 1.48
|
2.2 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 12h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
|
3.71 score on a scale
Standard Deviation 0.81
|
3.52 score on a scale
Standard Deviation 0.87
|
2.69 score on a scale
Standard Deviation 1.07
|
1.18 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: 24h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
|
3.82 score on a scale
Standard Deviation 0.86
|
3.79 score on a scale
Standard Deviation 0.82
|
2.35 score on a scale
Standard Deviation 1.20
|
1.93 score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 48h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
|
3.43 score on a scale
Standard Deviation 1.26
|
3.28 score on a scale
Standard Deviation 1.10
|
2.24 score on a scale
Standard Deviation 1.19
|
1.21 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 6h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
|
3.86 score on a scale
Standard Deviation 0.85
|
3.66 score on a scale
Standard Deviation 0.94
|
2.79 score on a scale
Standard Deviation 0.98
|
2 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 12h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
|
3.46 score on a scale
Standard Deviation 1.20
|
3.41 score on a scale
Standard Deviation 0.95
|
2.17 score on a scale
Standard Deviation 1.00
|
1.07 score on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 24h after cesarean section.visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Outcome measures
| Measure |
Group C
n=28 Participants
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 Participants
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
|
3.75 score on a scale
Standard Deviation 1.35
|
3.55 score on a scale
Standard Deviation 0.99
|
2.59 score on a scale
Standard Deviation 1.21
|
1.79 score on a scale
Standard Deviation 1.10
|
Adverse Events
Group C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group D1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group D2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group D3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group C
n=28 participants at risk
The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Normal Saline: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
|
Group D1
n=29 participants at risk
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
|
Group D2
n=29 participants at risk
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
|
Group D3
n=28 participants at risk
This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min.
Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h: Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
3.6%
1/28 • Number of events 1 • Every 6 hours post cesarean section, up to 48 hours in total.
|
6.9%
2/29 • Number of events 2 • Every 6 hours post cesarean section, up to 48 hours in total.
|
3.4%
1/29 • Number of events 1 • Every 6 hours post cesarean section, up to 48 hours in total.
|
3.6%
1/28 • Number of events 1 • Every 6 hours post cesarean section, up to 48 hours in total.
|
Additional Information
Dr. Shijiang Liu, Dr. Mei Gao
The First Affiliated Hospital of Nanjing Medical University
Phone: +862568303569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place