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

Neuromuscular Blockade Clinical Trial

Official title:

Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330172
• Other study ID #: B1312230009
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2014
• Last updated: September 6, 2016
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

Inclusion Criteria:

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

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

Study Design

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Other:
• Injection of neostigmine or sugammadex
At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation. During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.

Locations

Country	Name	City	State
Korea, Republic of	Eunsu Choi	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction score of surgical condition	satisfaction score of surgical condition using 7 point liker's scale	intraoperative surgical consition	No
Secondary	recovery time from neuromuscular blockade		from the injection of neostigmine or sugammadex up to 30 minutes	No