Hernia Abdominal Wall
Conditions
Brief summary
The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.
Interventions
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* laparoscopic hernia repair
Exclusion criteria
* patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil Infusion Rate | from pneumoperitoneum to removal of laparoscope, an average of 30 minutes | remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 64 |
| 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 | 64 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | bradycardia | 0 | 1 |
| Overall Study | conversion to open surgery | 3 | 2 |
Baseline characteristics
| Characteristic | Moderate NMB Group | Total | Deep NMB Group |
|---|---|---|---|
| Age, Continuous | 63 year | 63.5 year | 65 year |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 64 Participants | 128 Participants | 64 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 64 participants | 128 participants | 64 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 58 Participants | 117 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Remifentanil Infusion Rate
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50
Time frame: from pneumoperitoneum to removal of laparoscope, an average of 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Moderate NMB Group | Remifentanil Infusion Rate | 0.103 µg/kg/min |
| Deep NMB Group | Remifentanil Infusion Rate | 0.073 µg/kg/min |