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

Primary Purpose

Hernia Abdominal Wall

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Moderate neuromuscular block
Deep neuromuscular block
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hernia Abdominal Wall

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • laparoscopic hernia repair

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Moderate NMB group

Deep NMB group

Arm Description

Outcomes

Primary Outcome Measures

Remifentanil Infusion Rate
remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50

Secondary Outcome Measures

Full Information

First Posted
July 15, 2019
Last Updated
January 20, 2022
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04022733
Brief Title
Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia Abdominal Wall

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate NMB group
Arm Type
Placebo Comparator
Arm Title
Deep NMB group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Moderate neuromuscular block
Intervention Description
maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
Intervention Type
Drug
Intervention Name(s)
Deep neuromuscular block
Intervention Description
maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
Primary Outcome Measure Information:
Title
Remifentanil Infusion Rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: laparoscopic hernia repair Exclusion Criteria: patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Gyeonggido
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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