NCT03583021

Brief Summary

The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

June 28, 2018

Last Update Submit

May 28, 2020

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • optimal Ce of remifentanil

    Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia

    from the ene of surgery until endotracheal extubation

Study Arms (2)

sugammadex group

EXPERIMENTAL

Sugammadex group receives the intravenous sugammadex of 3 mg/kg.

Drug: Sugammadex Injectable Product

neostigmine group

PLACEBO COMPARATOR

Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.

Drug: Neostigmine Injectable Product

Interventions

Sugammadex Injectable ProductDRUG

Sugammadex of 3 mg/kg is injected.

sugammadex group
Neostigmine Injectable ProductDRUG

Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.

neostigmine group

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

  • BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Suwon, Seoul, South Korea

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ji Eun Kim

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

June 25, 2018

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

KR(1)