CClinicalTrials.gg
CompletedNCT04022733Updated Nov 9, 2023Results posted

Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy

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

Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hernia Abdominal Wall
03

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • laparoscopic hernia repair

Exclusion criteria

Exclusion Criteria:

  • patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
134 participants (actual)

Study arms

  • Placebo comparator
    Moderate NMB group

    Drug: Moderate neuromuscular block

  • Experimental
    Deep NMB group

    Drug: Deep neuromuscular block

Interventions

  • DrugModerate 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

  • DrugDeep neuromuscular block

    maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight

05

What researchers measure

Primary outcomes

  1. 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

06

Results

Posted Mar 15, 2022

Participant flow

Participant flow — Overall Study
MilestoneModerate NMB GroupDeep NMB Group
Started6767
Completed6464
Not completed33
Withdrew: Conversion to open surgery32
Withdrew: Bradycardia01

Outcome measures

PrimaryRemifentanil 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
Reported as:
Mean · µg/kg/min
Remifentanil Infusion Rate
µg/kg/minModerate NMB GroupDeep NMB Group
Remifentanil Infusion Rate0.103 (0.075 to 0.143)0.073 (0.056 to 0.097)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Moderate NMB Group0/67 (0%)0/67 (0%)0/67 (0%)
Deep NMB Group0/67 (0%)0/67 (0%)0/67 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(year)Moderate NMB GroupDeep NMB GroupTotal
Median63 (54 to 70)65 (51 to 75)63.5 (52.8 to 73)
Sex: Female, Male
Sex: Female, Male(Participants)Moderate NMB GroupDeep NMB GroupTotal
Female6511
Male5859117
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Moderate NMB GroupDeep NMB GroupTotal
American Indian or Alaska Native000
Asian6464128
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Moderate NMB GroupDeep NMB GroupTotal
South Korea6464128
07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
    Suwon, Gyeonggido, Korea, Republic of
08

References and documents

Study documents

  • Study protocol · Jan 18, 2022
  • Statistical analysis plan · Jan 18, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04022733
Lead sponsor
Ajou University School of Medicine
Responsible party
Ji Eun Kim (Assistant professor, Ajou University School of Medicine) — Principal investigator
First posted
Jul 17, 2019
Start date
Oct 30, 2019
Primary completion
Aug 3, 2021
Completion
Aug 3, 2021
Results posted
Mar 15, 2022
Last update
Nov 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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