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

NCT ID: NCT02330172

Last Updated: 2017-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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rocuronium 0.45 - neostigmine

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.

Group Type ACTIVE_COMPARATOR

Injection of neostigmine or sugammadex

Intervention Type 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.

rocuronium 0.9 - 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.

Group Type ACTIVE_COMPARATOR

Injection of neostigmine or sugammadex

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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neostigmin or sugammadex

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ah Young Oh

Role: PRINCIPAL_INVESTIGATOR

Bungdang Seoul National University

Locations

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Eunsu Choi

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Choi ES, Oh AY, Koo BW, Hwang JW, Han JW, Seo KS, Ahn SH, Jeong WJ. Comparison of reversal with neostigmine of low-dose rocuronium vs. reversal with sugammadex of high-dose rocuronium for a short procedure. Anaesthesia. 2017 Oct;72(10):1185-1190. doi: 10.1111/anae.13894. Epub 2017 May 11.

Reference Type DERIVED
PMID: 28493510 (View on PubMed)

Other Identifiers

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B1312230009

Identifier Type: -

Identifier Source: org_study_id

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