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OpenTrials
Completed

NCT Number: NCT00522587

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

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

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Key information

Conditions

Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fixed sevoflurane dose 1

Drug

Dose 1 of sevoflurane

Fixed sevoflurane dose 2

Drug

Dose 2 of sevoflurane

Fixed sevoflurane dose 3

Drug

Dose 3 of sevoflurane

Fixed sevoflurane dose 4

Drug

Dose 4 of sevoflurane

Fixed sevoflurane dose 5

Drug

Dose 5 of sevoflurane

Fixed sevoflurane dose 6

Drug

Dose 6 of sevoflurane

Fixed remifentanil dose 1

Drug

Dose 1 of remifentanil

Fixed remifentanil dose 2

Drug

Dose 2 of remifentanil

Fixed remifentanil dose 3

Drug

Dose 3 of remifentanil

Fixed remifentanil dose 4

Drug

Dose 4 of remifentanil

Fixed remifentanil dose 5

Drug

Dose 5 of remifentanil

Fixed remifentanil dose 6

Drug

Dose 6 of remifentanil

Primary outcomes

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

    Time frame: 60 to 90 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Aug 29, 2007
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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