Sugammadex: Effect on the Awareness Monitoring and Hemody... | NCT01301261

Studies
Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

NCT01301261

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

Jun 19, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Surgical Procedure, Unspecified

Interventions

sugammadex
Sugammadex 4 mg/kg
Sugammadex 16mg/kg

Countries

Greece

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Feb 2013Estimated

Completion Date

Not provided

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

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

Jun 18, 2012

Last Update Posted Date

Jun 19, 2012Estimated

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

Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Detailed Description

Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.

Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.

Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sugammadex 2 mg/kg	Active Comparator	2 mg/kg of sugammadex are given when a response of two counts of train of four are present	Drug: sugammadex
4 mg/kg of sugammadex	Active Comparator	4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears	Drug: Sugammadex 4 mg/kg
Sugammadex 16 mg/kg	Active Comparator	Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium	Drug: Sugammadex 16mg/kg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sugammadex	Drug	Sugammadex 2 mg/kg when a two count of train of four appears	sugammadex 2 mg/kg

Measure	Description	Time Frame
Entropy		every three minutes

Measure	Description	Time Frame
hemodynamics		every three minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients ASA I-III scheduled for elective major surgery
both sexes

Exclusion Criteria:

patients hypertensive
treated with antihypertensive drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Argyro Fassoulaki, MD, PhD, DEAA	Contact	+30210 9024530		fassoula@aretaieio.uoa.gr
Konstantinos Chondrogiannis, MD	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Aretaieio Hospital	Recruiting	Athens		11528	Greece

Type	Date	Date Unknown
Release	Mar 14, 2016
Unrelease		Yes

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 14, 2016		Yes

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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