Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

NCT ID: NCT04407078

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2021-01-06

Brief Summary

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

Detailed Description

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Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Conditions

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Gallbladder Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sugammadex group

Sugammadex group receives the intravenous sugammadex of 2 mg/kg.

Group Type EXPERIMENTAL

Sugammadex Injectable Product

Intervention Type DRUG

Sugammadex of 2 mg/kg is injected.

Neostigmine group

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

Group Type PLACEBO_COMPARATOR

Neostigmine Injectable Product

Intervention Type DRUG

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

Interventions

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Sugammadex Injectable Product

Sugammadex of 2 mg/kg is injected.

Intervention Type DRUG

Neostigmine Injectable Product

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ji Eun Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Suwon, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-OBS-18-273

Identifier Type: -

Identifier Source: org_study_id

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