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

June 22, 2018 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Moderate muscle relaxation
Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.
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.
EXPERIMENTAL: Deep muscle relaxation
Rocuronium is administered to maintain deep relaxation during operation.
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall incidence of postoperative sore throat
Time Frame: Within 24 hrs after operation
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
Within 24 hrs after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative sore throat
Time Frame: At 1,6, and 24 hrs after operation
The presence of sore throat is assessed.
At 1,6, and 24 hrs after operation
The severity of postoperative sore throat
Time Frame: At 1,6, and 24 hrs after operation
The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]).
At 1,6, and 24 hrs after operation
Incidence and severity of postoperative hoarseness
Time Frame: At 1,6, and 24 hrs after operation
Hoarseness is defined as a voice quality different from the preoperative voice and graded as follows: none (no hoarseness), mild (recognized by the patient), moderate (obvious to the investigator), and severe (aphonia).
At 1,6, and 24 hrs after operation
Postoperative analgesic consumption
Time Frame: Within 24 hrs after operation
The amount of patient-controlled analgesia and other analgesic medication used
Within 24 hrs after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jee-eun Chang, M.D, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ANTICIPATED)

July 14, 2018

Study Completion (ANTICIPATED)

August 14, 2019

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

January 1, 2018

First Posted (ACTUAL)

January 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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