Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.

Not Applicable

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Other: Injection of neostigmine or sugammadex

• Registration Number: NCT02330172
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.

Detailed Description

This study aims to make a comparison of surgical condition and recovery time between moderate neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular bloackade with reversal using sugammadex group.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2015-01-01
• Status Verified: 2015-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-12-15
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery under general anesthesia

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Exclusion Criteria

• BMI >25 or < 20 kg/m2 Patients taking intercurrent medication Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rocuronium 0.9 - sugammadex	Injection of neostigmine or sugammadex	When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation. When the end of operation,, a injection of neostigmine or sugammadex be administered.
rocuronium 0.45 - neostigmine	Injection of neostigmine or sugammadex	when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation. When the end of operation, a injection of neostigmine or sugammadex will be administered.

Primary Outcome Measures

Name	Time	Method
Laryngoscopic Score	At the beginning of surgery, the surgeon rated the laryngoscopy condition	Definitions for evaluation of Laryngoscopycondition.; : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.; Variables Excellent Good Poor

Secondary Outcome Measures

Name	Time	Method
Recovery Time From Neuromuscular Blockade	from the injection of neostigmine or sugammadex up to 30 minutes	We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9

Trial Locations

Locations (1)

Eunsu Choi; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of