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

Hernia Abdominal Wall Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022733
• Other study ID #: AJIRB-MED-THE-19-056
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: August 3, 2021

Study information

• Verified date: November 2023
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• laparoscopic hernia repair

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hernia Abdominal Wall
• Hernia, Ventral

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil Infusion Rate	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