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

Not Applicable

• Conditions: Sore Throat
• Interventions: Drug: Rocuronium(moderate); Drug: Rocuronium(deep)

• Registration Number: NCT03391700
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2018-01-01
• Study First Posted: 2018-01-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26
• Primary Completion: 2018-07-14
• Study Completion: 2019-08-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate muscle relaxation	Rocuronium(moderate)	Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.
Deep muscle relaxation	Rocuronium(deep)	Rocuronium is administered to maintain deep relaxation during operation.

Primary Outcome Measures

Name	Time	Method
Overall incidence of postoperative sore throat	Within 24 hrs after operation	The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative sore throat	At 1,6, and 24 hrs after operation	The presence of sore throat is assessed.
The severity of postoperative sore throat	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 \[worst pain imaginable\]).
Incidence and severity of postoperative hoarseness	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).
Postoperative analgesic consumption	Within 24 hrs after operation	The amount of patient-controlled analgesia and other analgesic medication used

Trial Locations

Locations (1)

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