The Dose of Sugammadex for Rapid Reversal of Profound Neu... | NCT01890057

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

NCT01890057

Sponsor

Severance Hospital

Status

Completed

Last Update Posted

Feb 4, 2014Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Anesthesia Recovery Period, Neuromuscular Blockade

Interventions

Sugammadex

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 26, 2013

First Posted Date

Jul 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2014

Last Update Posted Date

Feb 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young adults	Experimental	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	Drug: Sugammadex
Elderly adults	Experimental	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	Drug: Sugammadex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex	Drug	The dose of sugammadex	Elderly adults Young adults

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block		2 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077122	Sugammadex

Ancestor Terms

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

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Browse Branches

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