- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391700
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
June 22, 2018 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
206
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jee-Eun Chang, M.D
- Phone Number: 82-2-870-2517
- Email: sw411528@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 07061
- Recruiting
- Jee-Eun Chang
-
Contact:
- Jee-Eun Chang, M.D.
- Phone Number: +82-2-870-2517
- Email: sw411528@hanmail.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall incidence of postoperative sore throat
Time Frame: Within 24 hrs after operation
|
The overall cumulative incidence of postoperative sore throat is assessed in the 24-hr evaluation period
|
Within 24 hrs after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postoperative sore throat
Time Frame: At 1,6, and 24 hrs after operation
|
The presence of sore throat is assessed.
|
At 1,6, and 24 hrs after operation
|
The severity of postoperative sore throat
Time Frame: 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]).
|
At 1,6, and 24 hrs after operation
|
Incidence and severity of postoperative hoarseness
Time Frame: 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).
|
At 1,6, and 24 hrs after operation
|
Postoperative analgesic consumption
Time Frame: Within 24 hrs after operation
|
The amount of patient-controlled analgesia and other analgesic medication used
|
Within 24 hrs after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jee-eun Chang, M.D, SMG-SNU Boramae Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ANTICIPATED)
July 14, 2018
Study Completion (ANTICIPATED)
August 14, 2019
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
January 1, 2018
First Posted (ACTUAL)
January 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 22, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Signs and Symptoms, Respiratory
- Laryngeal Diseases
- Voice Disorders
- Pharyngitis
- Hoarseness
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Rocuronium
Other Study ID Numbers
- 20170601/10-2017-4/071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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