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NCT01980069 Clinical Trial

A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01980069
Other study ID # 4-2013-0451
Secondary ID
Status Completed
Phase N/A
First received November 1, 2013
Last updated April 22, 2015
Start date November 2013
Est. completion date October 2014

Study information
Verified date April 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board (Severance Hospital)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- adult patients of age over 20 years

- scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sugammadex
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.
• Neostigmine
In neostigmine group, neostigmine 50 ?/kg will be administered intravenously with glycopyrrolate 10 ?/kg when the T2 response appears on TOF stimuli.

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul Seodaemun-gu

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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