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

NCT00522587 | Completed Phase 2

• 1 other identifier: 2007/242
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• EEG depression and arousal reactions in response to different clinically relevant stimuli

  60 to 90 minutes

Study Arms (12)

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

EXPERIMENTAL

Fixed remifentanil dose 1

Drug: Fixed remifentanil dose 1

8

EXPERIMENTAL

Fixed remifentanil dose 2

Drug: Fixed remifentanil dose 2

9

EXPERIMENTAL

Fixed remifentanil dose 3

Drug: Fixed remifentanil dose 3

10

EXPERIMENTAL

Fixed remifentanil dose 4

Drug: Fixed remifentanil dose 4

11

EXPERIMENTAL

Fixed remifentanil dose 5

Drug: Fixed remifentanil dose 5

12

EXPERIMENTAL

Fixed remifentanil dose 6

Drug: Fixed remifentanil dose 6

Interventions

Fixed sevoflurane dose 1 DRUG

Dose 1 of sevoflurane

1

Fixed sevoflurane dose 2 DRUG

Dose 2 of sevoflurane

2

Fixed sevoflurane dose 3 DRUG

Dose 3 of sevoflurane

3

Fixed sevoflurane dose 4 DRUG

Dose 4 of sevoflurane

4

Fixed sevoflurane dose 5 DRUG

Dose 5 of sevoflurane

5

Fixed sevoflurane dose 6 DRUG

Dose 6 of sevoflurane

6

Fixed remifentanil dose 1 DRUG

Dose 1 of remifentanil

7

Fixed remifentanil dose 2 DRUG

Dose 2 of remifentanil

8

Fixed remifentanil dose 3 DRUG

Dose 3 of remifentanil

9

Fixed remifentanil dose 4 DRUG

Dose 4 of remifentanil

10

Fixed remifentanil dose 5 DRUG

Dose 5 of remifentanil

11

Fixed remifentanil dose 6 DRUG

Dose 6 of remifentanil

12

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

Study Officials

• Michel Struys, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 29, 2007
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2011
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

BE (1)