NCT04022733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 15, 2022

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

July 15, 2019

Results QC Date

November 8, 2021

Last Update Submit

November 7, 2023

Conditions

Hernia Abdominal Wall

Outcome Measures

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

    from pneumoperitoneum to removal of laparoscope, an average of 30 minutes

Study Arms (2)

Moderate NMB group

PLACEBO COMPARATOR
Drug: Moderate neuromuscular block

Deep NMB group

EXPERIMENTAL
Drug: Deep neuromuscular block

Interventions

Moderate neuromuscular blockDRUG

maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg

Moderate NMB group
Deep neuromuscular blockDRUG

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

Deep NMB group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic hernia repair

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Suwon, Gyeonggido, South Korea

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Associate professor in Anesthesiology Department
Organization
Ajou University
beye98@aumc.ac.kr
82-31-2195689

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

October 30, 2019

Primary Completion

August 3, 2021

Study Completion

August 3, 2021

Last Updated

November 9, 2023

Results First Posted

March 15, 2022

Record last verified: 2023-11

Locations

KR(1)