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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Anesthesia

Treatments: Drug: Fixed sevoflurane dose 6; Drug: Fixed sevoflurane dose 4; Drug: Fixed sevoflurane dose 5; Drug: Fixed remifentanil dose 5; Drug: Fixed sevoflurane dose 3; Drug: Fixed sevoflurane dose 1; Drug: Fixed remifentanil dose 3; Drug: Fixed remifentanil dose 2; Drug: Fixed remifentanil dose 4; Drug: Fixed remifentanil dose 6; Drug: Fixed remifentanil dose 1; Drug: Fixed sevoflurane dose 2

Study type: Interventional

Funder types: Other

Identifiers

NCT00522587

2007/242

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 12 patient groups

1

Experimental group

Description:

Fixed sevoflurane dose 1

Treatment:

Drug: Fixed sevoflurane dose 1

2

Experimental group

Description:

Fixed sevoflurane dose 2

Treatment:

Drug: Fixed sevoflurane dose 2

3

Experimental group

Description:

Fixed sevoflurane dose 3

Treatment:

Drug: Fixed sevoflurane dose 3

4

Experimental group

Description:

Fixed sevoflurane dose 4

Treatment:

Drug: Fixed sevoflurane dose 4

5

Experimental group

Description:

Fixed sevoflurane dose 5

Treatment:

Drug: Fixed sevoflurane dose 5

6

Experimental group

Description:

Fixed sevoflurane dose 6

Treatment:

Drug: Fixed sevoflurane dose 6

7

Experimental group

Description:

Fixed remifentanil dose 1

Treatment:

Drug: Fixed remifentanil dose 1

8

Experimental group

Description:

Fixed remifentanil dose 2

Treatment:

Drug: Fixed remifentanil dose 2

9

Experimental group

Description:

Fixed remifentanil dose 3

Treatment:

Drug: Fixed remifentanil dose 3

10

Experimental group

Description:

Fixed remifentanil dose 4

Treatment:

Drug: Fixed remifentanil dose 4

11

Experimental group

Description:

Fixed remifentanil dose 5

Treatment:

Drug: Fixed remifentanil dose 5

12

Experimental group

Description:

Fixed remifentanil dose 6

Treatment:

Drug: Fixed remifentanil dose 6