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

NCT ID: NCT00522587

Last Updated: 2013-01-30

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

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During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Fixed sevoflurane dose 1

Group Type EXPERIMENTAL

Fixed sevoflurane dose 1

Intervention Type DRUG

Dose 1 of sevoflurane

2

Fixed sevoflurane dose 2

Group Type EXPERIMENTAL

Fixed sevoflurane dose 2

Intervention Type DRUG

Dose 2 of sevoflurane

3

Fixed sevoflurane dose 3

Group Type EXPERIMENTAL

Fixed sevoflurane dose 3

Intervention Type DRUG

Dose 3 of sevoflurane

4

Fixed sevoflurane dose 4

Group Type EXPERIMENTAL

Fixed sevoflurane dose 4

Intervention Type DRUG

Dose 4 of sevoflurane

5

Fixed sevoflurane dose 5

Group Type EXPERIMENTAL

Fixed sevoflurane dose 5

Intervention Type DRUG

Dose 5 of sevoflurane

6

Fixed sevoflurane dose 6

Group Type EXPERIMENTAL

Fixed sevoflurane dose 6

Intervention Type DRUG

Dose 6 of sevoflurane

7

Fixed remifentanil dose 1

Group Type EXPERIMENTAL

Fixed remifentanil dose 1

Intervention Type DRUG

Dose 1 of remifentanil

8

Fixed remifentanil dose 2

Group Type EXPERIMENTAL

Fixed remifentanil dose 2

Intervention Type DRUG

Dose 2 of remifentanil

9

Fixed remifentanil dose 3

Group Type EXPERIMENTAL

Fixed remifentanil dose 3

Intervention Type DRUG

Dose 3 of remifentanil

10

Fixed remifentanil dose 4

Group Type EXPERIMENTAL

Fixed remifentanil dose 4

Intervention Type DRUG

Dose 4 of remifentanil

11

Fixed remifentanil dose 5

Group Type EXPERIMENTAL

Fixed remifentanil dose 5

Intervention Type DRUG

Dose 5 of remifentanil

12

Fixed remifentanil dose 6

Group Type EXPERIMENTAL

Fixed remifentanil dose 6

Intervention Type DRUG

Dose 6 of remifentanil

Interventions

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Fixed sevoflurane dose 1

Dose 1 of sevoflurane

Intervention Type DRUG

Fixed sevoflurane dose 2

Dose 2 of sevoflurane

Intervention Type DRUG

Fixed sevoflurane dose 3

Dose 3 of sevoflurane

Intervention Type DRUG

Fixed sevoflurane dose 4

Dose 4 of sevoflurane

Intervention Type DRUG

Fixed sevoflurane dose 5

Dose 5 of sevoflurane

Intervention Type DRUG

Fixed sevoflurane dose 6

Dose 6 of sevoflurane

Intervention Type DRUG

Fixed remifentanil dose 1

Dose 1 of remifentanil

Intervention Type DRUG

Fixed remifentanil dose 2

Dose 2 of remifentanil

Intervention Type DRUG

Fixed remifentanil dose 3

Dose 3 of remifentanil

Intervention Type DRUG

Fixed remifentanil dose 4

Dose 4 of remifentanil

Intervention Type DRUG

Fixed remifentanil dose 5

Dose 5 of remifentanil

Intervention Type DRUG

Fixed remifentanil dose 6

Dose 6 of remifentanil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Struys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2007/242

Identifier Type: -

Identifier Source: org_study_id

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