A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
1 other identifier
interventional
72
1 country
1
Brief Summary
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 23, 2015
April 1, 2015
11 months
November 1, 2013
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
surgical condition
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).
up to 1 hour after the end of surgery
Study Arms (2)
Neostigmine arm
EXPERIMENTALNeostigmine arm
Sugammadex arm
ACTIVE COMPARATORSugammadex arm
Interventions
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.
In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.
Eligibility Criteria
You may qualify if:
- adult patients of age over 20 years
- scheduled for laryngeal microsurgery under general anesthesia
You may not qualify if:
- anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure
- history of allergy to nondepolarizing muscle relaxant
- history of malignant hyperthermia
- pregnant woman
- body mass index over 35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seodaemun-gu, 120-752, South Korea
Related Publications (1)
Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368.
PMID: 26582847DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 8, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 23, 2015
Record last verified: 2015-04