An interventional study of Moderate neuromuscular block and Deep neuromuscular block in Hernia Abdominal Wall, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Drug: Moderate neuromuscular block
Drug: Deep 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
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
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
| Milestone | Moderate NMB Group | Deep NMB Group |
|---|---|---|
| Started | 67 | 67 |
| Completed | 64 | 64 |
| Not completed | 3 | 3 |
| Withdrew: Conversion to open surgery | 3 | 2 |
| Withdrew: Bradycardia | 0 | 1 |
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50
| µg/kg/min | Moderate NMB Group | Deep NMB Group |
|---|---|---|
| Remifentanil Infusion Rate | 0.103 (0.075 to 0.143) | 0.073 (0.056 to 0.097) |
Collected over from the start of anesthesia induction until discharge of post-anesthesia care unit, an average of 130 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate NMB Group | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Deep NMB Group | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Age, Continuous(year) | Moderate NMB Group | Deep NMB Group | Total |
|---|---|---|---|
| Median | 63 (54 to 70) | 65 (51 to 75) | 63.5 (52.8 to 73) |
| Sex: Female, Male(Participants) | Moderate NMB Group | Deep NMB Group | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 58 | 59 | 117 |
| Race (NIH/OMB)(Participants) | Moderate NMB Group | Deep NMB Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 64 | 64 | 128 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Moderate NMB Group | Deep NMB Group | Total |
|---|---|---|---|
| South Korea | 64 | 64 | 128 |
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Ajou University School of Medicine