Trial Outcomes & Findings for Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia (NCT NCT05124704)
NCT ID: NCT05124704
Last Updated: 2025-01-09
Results Overview
Recording propofol EC50 for inducing loss of conciousness between general with epidural anesthesia group and general group with propofol effect-site target-controlled infusion (TCI) system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
From anesthesia induction to patient loss of consciousness, an average of 5 minutes.
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Combined Epidural With General Anesthesia
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia
Baseline characteristics by cohort
| Measure |
Combined Epidural With General Anesthesia
n=30 Participants
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
n=30 Participants
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
Total
n=60 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
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
62 years
n=7 Participants
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From anesthesia induction to patient loss of consciousness, an average of 5 minutes.Recording propofol EC50 for inducing loss of conciousness between general with epidural anesthesia group and general group with propofol effect-site target-controlled infusion (TCI) system
Outcome measures
| Measure |
Combined Epidural With General Anesthesia
n=30 Participants
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
n=30 Participants
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
|---|---|---|
|
Propofol EC50 for Inducing Loss of Conciousness
|
2.97 ug/ml
Standard Deviation 0.44
|
3.36 ug/ml
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: From anesthesia induction to the patient loss of consciousness, an average of 5 minutes.Recording the effect-site concentration of propofol (Ceprop) which showed on target-controlled infusion (TCI) system at loss of consciousness and discontinuation of anesthetics
Outcome measures
| Measure |
Combined Epidural With General Anesthesia
n=30 Participants
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
n=30 Participants
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
|---|---|---|
|
Predicted Effect-site Concentration of Propofol (Ceprop) at Certain Time Points
|
2.63 ug/ml
Standard Deviation 0.38
|
1.97 ug/ml
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: From anesthesia induction to the end of surgery, an average of 2.5 hours.Recording the total propofol and reminfentanil consumption during surgery
Outcome measures
| Measure |
Combined Epidural With General Anesthesia
n=30 Participants
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
n=30 Participants
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
|---|---|---|
|
Anesthetics Consumption
|
0.11 Propofol (mg/Kg.min)
Standard Deviation 0.02
|
0.13 Propofol (mg/Kg.min)
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: 0-14 days postoperativelyRecording the first postoperative exhaust time by daily follow up
Outcome measures
| Measure |
Combined Epidural With General Anesthesia
n=30 Participants
Patients in this group received 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction.Followed by a continuous infusion of 4-6 ml 0.375% ropivacaine was applied using micro-infusion pump after induction during surgery.
5-8ml 0.375% ropivacaine: 5-8ml of 0.375% ropivacaine depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction in experimental group. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
General Anesthesia
n=30 Participants
In this group, same dose of normal saline was administered before induction and during surgery.
5-8ml normal saline: 5-8ml of normal saline depend on the height and weight of the patient was administrated through the epidural catheter at least 20 min before induction. Followed by a continuous infusion of 4-6 ml/h using micro-infusion pump after induction during surgery.
|
|---|---|---|
|
Postoperative Exhaust Time
|
78.0 hours
Interval 58.5 to 110.0
|
85.0 hours
Interval 76.5 to 104.3
|
Adverse Events
Combined Epidural With General Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Anesthesia
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place