Trial Outcomes & Findings for Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy (NCT NCT04022733)
NCT ID: NCT04022733
Last Updated: 2023-11-09
Results Overview
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
from pneumoperitoneum to removal of laparoscope, an average of 30 minutes
Results posted on
2023-11-09
Participant Flow
Participant milestones
| Measure |
Moderate NMB Group
Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
|
Deep NMB Group
Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
67
|
|
Overall Study
COMPLETED
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Moderate NMB Group
Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
|
Deep NMB Group
Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
|
|---|---|---|
|
Overall Study
conversion to open surgery
|
3
|
2
|
|
Overall Study
bradycardia
|
0
|
1
|
Baseline Characteristics
Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy
Baseline characteristics by cohort
| Measure |
Moderate NMB Group
n=64 Participants
Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
|
Deep NMB Group
n=64 Participants
Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 year
n=99 Participants
|
65 year
n=107 Participants
|
63.5 year
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
64 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
64 participants
n=99 Participants
|
64 participants
n=107 Participants
|
128 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: from pneumoperitoneum to removal of laparoscope, an average of 30 minutesremifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50
Outcome measures
| Measure |
Moderate NMB Group
n=64 Participants
Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
|
Deep NMB Group
n=64 Participants
Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
|
|---|---|---|
|
Remifentanil Infusion Rate
|
0.103 µg/kg/min
Interval 0.075 to 0.143
|
0.073 µg/kg/min
Interval 0.056 to 0.097
|
Adverse Events
Moderate NMB Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep NMB 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
Associate professor in Anesthesiology Department
Ajou University
Phone: 82-31-2195689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place