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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
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Sugammadex Drug: Neostigmine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neostigmine arm
Neostigmine arm
Drug: Neostigmine
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
Sugammadex arm
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.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Korea, Republic of
Severance Hospital
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01980069     History of Changes
Other Study ID Numbers: 4-2013-0451
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Yonsei University:
Sugammadex
Neostigmine
Surgery

Additional relevant MeSH terms:
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents