Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia
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|ClinicalTrials.gov Identifier: NCT03391700|
Recruitment Status : Unknown
Verified June 2018 by Jin-Young Hwang, SMG-SNU Boramae Medical Center.
Recruitment status was: Recruiting
First Posted : January 5, 2018
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sore Throat||Drug: Rocuronium(deep) Drug: Rocuronium(moderate)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||July 14, 2018|
|Estimated Study Completion Date :||August 14, 2019|
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).
- 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
- The incidence of postoperative sore throat [ Time Frame: At 1,6, and 24 hrs after operation ]The presence of sore throat is assessed.
- 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]).
- 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).
- Postoperative analgesic consumption [ Time Frame: Within 24 hrs after operation ]The amount of patient-controlled analgesia and other analgesic medication used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391700
|Contact: Jee-Eun Chang, M.Demail@example.com|
|Korea, Republic of|
|Seoul, Korea, Republic of, 07061|
|Contact: Jee-Eun Chang, M.D. +82-2-870-2517 firstname.lastname@example.org|
|Principal Investigator:||Jee-eun Chang, M.D||SMG-SNU Boramae Medical Center|