Trial Outcomes & Findings for Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. (NCT NCT03809182)
NCT ID: NCT03809182
Last Updated: 2020-10-01
Results Overview
Change of baseline glucose levels within the first 12 postoperative hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidine
Results posted on
2020-10-01
Participant Flow
The patients were recruited at the Pontifical Catholic University Hospital between 2012 and 2013. Twenty patients were assigned to each arm to allow some dropouts. Nonetheless, every randomized patient included in the study was analyzed at the end of it (intention to treat analysis).
No patient was excluded from the study after being assigned to one arm/group.
Participant milestones
| Measure |
Dexmedetomidine
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same bolus and infusion rate used in the dexmedetomidine group.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in the case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pump was installed and the patient was discharged to his/her room.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
32 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
34.4 kg/m^2
STANDARD_DEVIATION 2.5 • n=5 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 3.6 • n=7 Participants
|
34.8 kg/m^2
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
ASA physical status II
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Risk score for postoperative nausea and vomiting (PONV) in adults
0 risk factor
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Risk score for postoperative nausea and vomiting (PONV) in adults
1 risk factor
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Risk score for postoperative nausea and vomiting (PONV) in adults
2 risk factors
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Risk score for postoperative nausea and vomiting (PONV) in adults
3 risk factors
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Risk score for postoperative nausea and vomiting (PONV) in adults
4 risk factors
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline HbA1c
|
5.4 Percentage
STANDARD_DEVIATION 0.2 • n=5 Participants
|
5.4 Percentage
STANDARD_DEVIATION 0.4 • n=7 Participants
|
5.4 Percentage
STANDARD_DEVIATION 0.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidinePopulation: All recruited population was analyzed.
Change of baseline glucose levels within the first 12 postoperative hours.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Plasmatic Glucose Levels (mg/dl).
Baseline level (T0)
|
80 mg/dl
Standard Deviation 15
|
82 mg/dl
Standard Deviation 8
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 2 (T1)
|
114 mg/dl
Standard Deviation 29
|
111 mg/dl
Standard Deviation 20
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 4 (T2)
|
124 mg/dl
Standard Deviation 25
|
129 mg/dl
Standard Deviation 17
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 6 (T3)
|
131 mg/dl
Standard Deviation 60
|
120 mg/dl
Standard Deviation 16
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 8 (T4)
|
122 mg/dl
Standard Deviation 41
|
118 mg/dl
Standard Deviation 17
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 10 (T5)
|
130 mg/dl
Standard Deviation 62
|
117 mg/dl
Standard Deviation 18
|
|
Plasmatic Glucose Levels (mg/dl).
Hour 12 (T6)
|
125 mg/dl
Standard Deviation 31
|
117 mg/dl
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Baseline levels(T0) and at hour 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), and 12(T6) after the onset of bolus and infusion of dexmedetomidineChange of baseline insulin levels within the first 12 postoperative hours.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Plasmatic Insulin Levels (uU/ml).
Hour 8 (T4)
|
16.6 uU/dl
Standard Deviation 8.9
|
21.5 uU/dl
Standard Deviation 10.4
|
|
Plasmatic Insulin Levels (uU/ml).
Baseline level (T0)
|
10.5 uU/dl
Standard Deviation 6
|
11.2 uU/dl
Standard Deviation 6
|
|
Plasmatic Insulin Levels (uU/ml).
Hour 2 (T1)
|
11.8 uU/dl
Standard Deviation 9
|
19.9 uU/dl
Standard Deviation 11.8
|
|
Plasmatic Insulin Levels (uU/ml).
Hour 4 (T2)
|
16.7 uU/dl
Standard Deviation 9.5
|
30.3 uU/dl
Standard Deviation 19.9
|
|
Plasmatic Insulin Levels (uU/ml).
Hour 6 (T3)
|
16.8 uU/dl
Standard Deviation 11.4
|
23 uU/dl
Standard Deviation 11.4
|
|
Plasmatic Insulin Levels (uU/ml).
Hour 10 (T5)
|
16 uU/dl
Standard Deviation 10
|
24 uU/dl
Standard Deviation 17.7
|
|
Plasmatic Insulin Levels (uU/ml).
Hour 12 (T6)
|
16.6 uU/dl
Standard Deviation 9.2
|
25.9 uU/dl
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: Since the beginning of anesthesia until the end of it, an average of one hour and a half.Amount of fentanyl (ug/kg) intraoperatively administered.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Fentanyl Consumption.
|
6.0 mcg/kg
Standard Deviation 2.2
|
7 mcg/kg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: At 24h postoperative hours.Morphine consumption in the first 24 postoperative hours.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Amount (mg) of Morphine Consumed.
|
26 mg
Standard Deviation 14.4
|
18.4 mg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5), 12(T6) and 24(T7).Visual analogue scale (VAS), provided by patients, ranging from 0 to 10 (0= no pain and 10= worst possible pain). We considered a pain score between 1-3, 4-6 and 7-10 as mild, moderate and severe pain, respectively.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 2 (T1) Pain at rest
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 4.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 2 (T1) Pain at movement
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 5.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 4 (T2) Pain at rest
|
4 units on a scale
Interval 2.0 to 5.0
|
3 units on a scale
Interval 2.0 to 4.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 4 (T2) Pain at movement
|
5 units on a scale
Interval 4.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 6 (T3) Pain at rest
|
3 units on a scale
Interval 1.0 to 5.0
|
2 units on a scale
Interval 2.0 to 3.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 6 (T3) Pain at movement
|
4 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 2.0 to 5.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 8 (T4) Pain at rest
|
3 units on a scale
Interval 1.0 to 5.0
|
1 units on a scale
Interval 0.0 to 3.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 8 (T4) Pain at movement
|
4 units on a scale
Interval 3.0 to 7.0
|
4 units on a scale
Interval 2.0 to 4.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 10 (T5) Pain at rest
|
3 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 0.0 to 2.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 10 (T5) Pain at movement
|
5 units on a scale
Interval 3.0 to 6.0
|
3 units on a scale
Interval 2.0 to 5.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 12 (T6) Pain at rest
|
3 units on a scale
Interval 0.0 to 4.0
|
1 units on a scale
Interval 0.0 to 2.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 12 (T6) Pain at movement
|
3 units on a scale
Interval 2.0 to 5.0
|
3 units on a scale
Interval 2.0 to 4.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 24 (T7) Pain at rest
|
2 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 2.0
|
|
Pain Scores in the First 24 Postoperative Hours.
Hour 24 (T7) Pain at movement
|
3 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: At postoperative hours 2(T1), 4(T2), 6(T3), 8(T4), 10(T5) and 12(T6).Sedation-agitation scale (SAS), ranging from 1 to 7 (1=unarousable, 2=very sedated, 3=sedated, 4=calm and cooperative, 5=agitated, 6=very agitated and 7=dangerous agitation).
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 2 (T1)
|
3 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 4 (T2)
|
4 score on a scale
Interval 3.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 6 (T3)
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 8 (T4)
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 10 (T5)
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Sedation-agitation Scores in the First 12 Postoperative Hours.
Hour 12 (T6)
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Postoperative nausea and vomiting during the first 12 postoperative hours.Number of patients with postoperative nausea and vomiting in the first 12 postoperative hours.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
After anesthesia induction, patients who were randomized to the Dexmedetomidine group received:
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 Participants
After anesthesia induction, patients who were randomized to the Placebo group received:
0.9% Sodium-chloride: The same rate infusion used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Postoperative Nausea and Vomiting.
|
16 Participants
|
19 Participants
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
0.9% Sodium-chloride
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine
n=20 participants at risk
After anesthesia induction, patients who were randomized to the Dexmedetomidine group, received a bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
Dexmedetomidine: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
0.9% Sodium-chloride
n=20 participants at risk
After anesthesia induction, patients who were randomized to the Placebo group received a bolus and infusion of 0.9% normal saline at the same rate as the Dexmedetomidine group until the end of surgery. In the case of intraoperative increment of the blood pressure and/or heart rate more than 25% from its baseline, fentanyl 1ug/kg was administered.
0.9% Sodium-chloride: The same dose used in the dexmedetomidine group (bolus and infusion).
Fentanyl: Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
Morphine Sulfate: Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 a patient-controlled analgesia pumps were installed and the patients were discharged to their room.
|
|---|---|---|
|
Cardiac disorders
Isolated hypotension
|
10.0%
2/20 • Number of events 2 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
20.0%
4/20 • Number of events 4 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
|
Cardiac disorders
Isolated Bradycardia
|
35.0%
7/20 • Number of events 7 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
20.0%
4/20 • Number of events 4 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
|
Cardiac disorders
Hypotension associated with bradycardia
|
50.0%
10/20 • Number of events 10 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
10.0%
2/20 • Number of events 2 • Intraop and 24 hours post-surgery.
Record of vital signs was written in the anesthesia sheet. Non-serious adverse events were presented as follow: Hypotension Bradycardia Hypotension associated with bradycardia
|
Additional Information
Mauricio Ibacache MD
Pontificia Universidad Católica de Chile
Phone: +56984421425
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place