Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Primary Purpose
Sore Throat
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium(deep)
Rocuronium(moderate)
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat focused on measuring muscle relaxant
Eligibility Criteria
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
Sites / Locations
- Jee-Eun ChangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Moderate muscle relaxation
Deep muscle relaxation
Arm Description
Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.
Rocuronium is administered to maintain deep relaxation during operation.
Outcomes
Primary Outcome Measures
Overall incidence of postoperative sore throat
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
Secondary Outcome Measures
The incidence of postoperative sore throat
The presence of sore throat is assessed.
The severity of postoperative sore throat
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
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
The amount of patient-controlled analgesia and other analgesic medication used
Full Information
NCT ID
NCT03391700
First Posted
November 9, 2017
Last Updated
June 22, 2018
Sponsor
SMG-SNU Boramae Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03391700
Brief Title
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Official Title
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 14, 2018 (Anticipated)
Study Completion Date
August 14, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SMG-SNU Boramae Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
muscle relaxant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate muscle relaxation
Arm Type
Active Comparator
Arm Description
Rocuronium is administered to maintain moderate relaxation during operation. This is conventional muscle relaxation level of this institute.
Arm Title
Deep muscle relaxation
Arm Type
Experimental
Arm Description
Rocuronium is administered to maintain deep relaxation during operation.
Intervention Type
Drug
Intervention Name(s)
Rocuronium(deep)
Intervention Description
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).
Intervention Type
Drug
Intervention Name(s)
Rocuronium(moderate)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall incidence of postoperative sore throat
Description
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
Time Frame
Within 24 hrs after operation
Secondary Outcome Measure Information:
Title
The incidence of postoperative sore throat
Description
The presence of sore throat is assessed.
Time Frame
At 1,6, and 24 hrs after operation
Title
The severity of postoperative sore throat
Description
The severity of sore throat is assessed by using a 100-point numerical ratig scale (NRS, 0 [no pain], 100 [worst pain imaginable]).
Time Frame
At 1,6, and 24 hrs after operation
Title
Incidence and severity of postoperative hoarseness
Description
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).
Time Frame
At 1,6, and 24 hrs after operation
Title
Postoperative analgesic consumption
Description
The amount of patient-controlled analgesia and other analgesic medication used
Time Frame
Within 24 hrs after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jee-Eun Chang, M.D
Phone
82-2-870-2517
Email
sw411528@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee-eun Chang, M.D
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jee-Eun Chang
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee-Eun Chang, M.D.
Phone
+82-2-870-2517
Email
sw411528@hanmail.net
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
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