Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

NCT ID: NCT03391700

Last Updated: 2018-06-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-08-14

Brief Summary

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Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Detailed Description

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In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Conditions

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Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Moderate muscle relaxation

Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.

Group Type ACTIVE_COMPARATOR

Rocuronium(moderate)

Intervention Type DRUG

In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.

Deep muscle relaxation

Rocuronium is administered to maintain deep relaxation during operation.

Group Type EXPERIMENTAL

Rocuronium(deep)

Intervention Type DRUG

In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).

Interventions

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Rocuronium(deep)

In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).

Intervention Type DRUG

Rocuronium(moderate)

In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria

* Hoarseness and sore throat existed before surgery
* Upper respiratory infection
* Known or predicted difficult airway
* Liver, renal disease
* Requirement of postoperative ventilator care
* the operation within 2hrs
* Laparoscopic surgery
* Other positions except supine during surgery
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jee-eun Chang, M.D

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Jee-Eun Chang

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jee-Eun Chang, M.D

Role: CONTACT

82-2-870-2517

Facility Contacts

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Jee-Eun Chang, M.D.

Role: primary

+82-2-870-2517

Other Identifiers

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20170601/10-2017-4/071

Identifier Type: -

Identifier Source: org_study_id

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