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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01980069

Enrollment

Registered

2013-11-08

Start date

2013-11-30

Completion date

2014-10-31

Last updated

2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

Sugammadex, Neostigmine, Surgery

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.

Interventions

DRUGSugammadex

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.

DRUGNeostigmine

In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
surgical condition	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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026