The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients

NCT ID: NCT01890057

Last Updated: 2014-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.

Detailed Description

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A previous study reported that elderly patients required a longer time to recover from rocuronium induced neuromuscular block compared to younger patients. Therefore, the aim of this study is to find out the dose of sugammadex for rapid recovery from profound neuromuscular block in young and elderly adult patients.

Conditions

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Anesthesia Recovery Period, Neuromuscular Blockade

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Young adults

To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

The dose of sugammadex

Elderly adults

To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

The dose of sugammadex

Interventions

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Sugammadex

The dose of sugammadex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20-40 years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.

Exclusion Criteria

* anticipated difficult intubation
* neuromuscular, hepatic or renal disorders
* drug allergy
* body mass index \>30 kg/m2 or body mass index \<18 kg/m2
* emergency surgery
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2013-0280

Identifier Type: -

Identifier Source: org_study_id

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