Sevoflurane-Remifentanil Interaction: Multiple Response S... | NCT00522587

Studies
Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

NCT00522587

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 30, 2013Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Anesthesia

Interventions

Fixed sevoflurane dose 1
Fixed sevoflurane dose 2
Fixed sevoflurane dose 3
Fixed sevoflurane dose 4
Fixed sevoflurane dose 5
Fixed sevoflurane dose 6
Fixed remifentanil dose 1
Fixed remifentanil dose 2
Fixed remifentanil dose 3
Fixed remifentanil dose 4
Fixed remifentanil dose 5
Fixed remifentanil dose 6

Countries

Belgium

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

Status Module

Record Verification Date

Jan 2013

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

Apr 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 29, 2007Estimated

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

Jan 29, 2013

Last Update Posted Date

Jan 30, 2013Estimated

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

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fixed sevoflurane dose 1	Drug: Fixed sevoflurane dose 1
2	Experimental	Fixed sevoflurane dose 2	Drug: Fixed sevoflurane dose 2
3	Experimental	Fixed sevoflurane dose 3	Drug: Fixed sevoflurane dose 3
4	Experimental	Fixed sevoflurane dose 4	Drug: Fixed sevoflurane dose 4
5	Experimental	Fixed sevoflurane dose 5	Drug: Fixed sevoflurane dose 5
6	Experimental	Fixed sevoflurane dose 6	Drug: Fixed sevoflurane dose 6
7

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fixed sevoflurane dose 1	Drug	Dose 1 of sevoflurane	1
Fixed sevoflurane dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG depression and arousal reactions in response to different clinically relevant stimuli		60 to 90 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesia class I and II patients
Aged 18-60 years
Scheduled for surgery under general anesthesia

Exclusion Criteria:

Weight less than 70% or more than 130% of ideal body weight
Neurological disorder
Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator [AICD])
Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
Gastric diseases including reflux, endocrinological diseases
Recent use of psycho-active medication, including alcohol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel Struys, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.