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Completed

NCT Number: NCT02330172

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

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eunsu Choi

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of neostigmine or sugammadex

Other

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.

Other names: neostigmin or sugammadex

Primary outcomes

  1. Laryngoscopic Score

    Time frame: 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 outcomes

  1. Recovery Time From Neuromuscular Blockade

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2015
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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