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

Sponsor
SMG-SNU Boramae Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03391700
Collaborator
(none)
206
1
2
24.4
8.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
206 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jul 14, 2018
Anticipated Study Completion Date :
Aug 14, 2019

Arms and Interventions

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.

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.

Experimental: Deep muscle relaxation

Rocuronium is administered to maintain deep relaxation during operation.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The incidence of postoperative sore throat [At 1,6, and 24 hrs after operation]

    The presence of sore throat is assessed.

  2. 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]).

  3. 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).

  4. Postoperative analgesic consumption [Within 24 hrs after operation]

    The amount of patient-controlled analgesia and other analgesic medication used

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jee-Eun Chang Seoul Korea, Republic of 07061

Sponsors and Collaborators

  • SMG-SNU Boramae Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Young Hwang, associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier:
NCT03391700
Other Study ID Numbers:
  • 20170601/10-2017-4/071
First Posted:
Jan 5, 2018
Last Update Posted:
Jun 26, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jin-Young Hwang, associate professor, SMG-SNU Boramae Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2018