Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness

Completed

• Conditions: Sore Throat
• Interventions: Drug: Rocuronium

• Registration Number: NCT03397797
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.

Detailed Description

The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-29
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with muscle relaxant	Rocuronium	Rocuronium is used during the operation to maintain moderate relaxation.

Primary Outcome Measures

Name	Time	Method
Overall cumulative incidence of postoperative sore throat	Within 24 hr evaluation period after operation	The incidence sore throat is assessed by the presence of sore throat
Overall cumulative incidence of postoperative hoarseness	Within 24 hr evaluation period after operation	The incidence sore throat is assessed by the degree of hoarseness

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative sore throat	At 1,6, and 24 hr after operation	The incidence of sore throat is assessed by the presence of sore throat.
Severity of postoperative sore throat	At 1,6, and 24 hr after operation	A 0-100 mm NRS is used to evaluate the severity of sore throat (0, no pain; 100, worst pain imaginable).
Incidence and severity of postoperative hoarseness	At 1,6, and 24 hr 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).
Post operative analgesic consumption	within 24 hrs after operation	the amount of patient-controlled analgesia and other analgesic medication consumed

Trial Locations

Locations (1)

Jee-Eun Chang; 🇰🇷 Seoul, Korea, Republic of