A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
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|ClinicalTrials.gov Identifier: NCT01980069|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia||Drug: Sugammadex Drug: Neostigmine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Neostigmine arm
In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.
Active Comparator: Sugammadex arm
In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus.
- surgical condition [ Time Frame: up to 1 hour after the end of surgery ]Primary outcome is the proportion of patients who have clinically acceptable surgical condition. The surgeon will evaluate the surgical condition as a surgical rating scale during surgery (extremely poor condition, poor condition, acceptable condition, good condition, optimal condition).
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): NCT01980069
|Korea, Republic of|
|Seoul, Seodaemun-gu, Korea, Republic of, 120-752|