Trial Outcomes & Findings for The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl (NCT NCT01748071)
NCT ID: NCT01748071
Last Updated: 2013-11-25
Results Overview
According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Recruitment status
COMPLETED
Target enrollment
120 participants
Primary outcome timeframe
10 minutes after the procedure
Results posted on
2013-11-25
Participant Flow
Participant milestones
| Measure |
Sufentanil Group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sufentanil Group
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
Baseline Characteristics
The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl
Baseline characteristics by cohort
| Measure |
Sufentanil Group
n=40 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=40 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
Total
n=120 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
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
120 Participants
n=483 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
|
|
Age Continuous
|
49 years
STANDARD_DEVIATION 12 • n=93 Participants
|
47 years
STANDARD_DEVIATION 13 • n=4 Participants
|
49 years
STANDARD_DEVIATION 11 • n=27 Participants
|
48 years
STANDARD_DEVIATION 13 • n=483 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
120 Participants
n=483 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
|
|
Region of Enrollment
China
|
40 participants
n=93 Participants
|
40 participants
n=4 Participants
|
40 participants
n=27 Participants
|
120 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 10 minutes after the procedureAccording to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Outcome measures
| Measure |
Sufentanil Group
n=38 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=38 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Mean Pressure Pain Threshold
|
9.93 kg/cm2
Standard Deviation 3.50
|
6.20 kg/cm2
Standard Deviation 3.00
|
2.36 kg/cm2
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: 10 minutes after the procedureAccording to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.
Outcome measures
| Measure |
Sufentanil Group
n=38 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=38 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Mean Value of Narco-trend Index
|
50.9 units on a scale
Standard Deviation 18.3
|
70.4 units on a scale
Standard Deviation 27.3
|
93.7 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 10 minutes after the procedureAccording to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
Outcome measures
| Measure |
Sufentanil Group
n=38 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=38 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Mean Arterial Pressure
|
90.1 mmHg
Standard Deviation 9.7
|
89.7 mmHg
Standard Deviation 12.8
|
90.3 mmHg
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 10 minutes after the procedureAccording to the measurement of heart rate before and after intravenous injection of opioid analgesics
Outcome measures
| Measure |
Sufentanil Group
n=38 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=38 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Mean Heart Rate
|
77.9 beats per minute
Standard Deviation 10.1
|
74.4 beats per minute
Standard Deviation 12.9
|
77.6 beats per minute
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 10 minutes after the procedureAccording to the measurement of respiratory frequency after intravenous injection of opioid analgesics
Outcome measures
| Measure |
Sufentanil Group
n=38 Participants
Grouped by intravenous injection of sufentanil at the time of anesthesia induction
|
Fentanyl Group
n=38 Participants
Grouped by intravenous injection of fentanyl at the time of anesthesia induction
|
Saline Group
n=40 Participants
Grouped by intravenous injection of saline before the time of anesthesia induction
|
|---|---|---|---|
|
Mean Respiratory Frequency
|
13.9 breaths per minute
Standard Deviation 3.3
|
12.3 breaths per minute
Standard Deviation 2.2
|
16.1 breaths per minute
Standard Deviation 3.1
|
Adverse Events
Sufentanil Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fentanyl Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Xianwei Zhang
Huazhong University of Science&Technology
Phone: 027 83662853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place