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

November 7, 2023 updated by: Ji Eun Kim, Ajou University School of Medicine

A Double-blind, Randomized Study to Compare the Remifentanil Requirements in Deep Versus Moderate Neuromuscular Blocks During the Surgical Pleth Index-guided Analgesia in Patients Undergoing General Anesthesia for Laparoscopic Herniorrhaphy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • laparoscopic hernia repair

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Moderate NMB group
Drug: 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
Experimental: Deep NMB group
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remifentanil Infusion Rate
Time Frame: 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
from pneumoperitoneum to removal of laparoscope, an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Actual)

August 3, 2021

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-THE-19-056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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