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

NCT03391700 | Unknown DMC

• 1 other identifier: 20170601/10-2017-4/071
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sore Throat

Keywords

muscle relaxant

Outcome Measures

Primary Outcomes (1)

• Overall incidence of postoperative sore throat

  The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period

  Within 24 hrs after operation

Secondary Outcomes (4)

• The incidence of postoperative sore throat

  At 1,6, and 24 hrs after operation

• The severity of postoperative sore throat

  At 1,6, and 24 hrs after operation

• Incidence and severity of postoperative hoarseness

  At 1,6, and 24 hrs after operation

• Postoperative analgesic consumption

  Within 24 hrs after operation

Study Arms (2)

Moderate muscle relaxation

ACTIVE COMPARATOR

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

Drug: Rocuronium(moderate)

Deep muscle relaxation

EXPERIMENTAL

Rocuronium is administered to maintain deep relaxation during operation.

Drug: Rocuronium(deep)

Interventions

Rocuronium(deep) DRUG

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

Deep muscle relaxation

Rocuronium(moderate) 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.

Moderate muscle relaxation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement for mechanical ventilation under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

Jee-Eun Chang

Seoul, 07061, South Korea

RECRUITING

MeSH Terms

Conditions

Pharyngitis; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jee-eun Chang, M.D

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee-Eun Chang, M.D

CONTACT

82-2-870-2517; sw411528@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: January 5, 2018
• Study Start: August 1, 2017
• Primary Completion: July 14, 2018
• Study Completion: August 14, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)