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Nitrous Oxide - Sevoflurane-Remifentanil Interaction

This study has been terminated.
(Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01103193
First received: March 19, 2010
Last updated: May 7, 2012
Last verified: May 2012
History of Changes

March 19, 2010
May 7, 2012
February 2010
May 2010   (final data collection date for primary outcome measure)
To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil [ Time Frame: Every 12 minutes during induction and maintenance of anesthesia ] [ Designated as safety issue: No ]
The interaction is studied on response surfaces including several clinical endpoints: the observer assessment of alertness and sedation scale, the heart rate, pulse oximetry, blood pressure, EEG and the derived parameters from it: spectral entropy and BIS
Same as current
Complete list of historical versions of study NCT01103193 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nitrous Oxide - Sevoflurane-Remifentanil Interaction
Nitrous Oxide - Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance.

patients are allocated to one of the two study groups.

In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.

During the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.

The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia
  • Drug: remifentanil injected
    mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.
  • Drug: sevoflurane in step up concentration
    of 60% nitrous oxide and 40% oxygen is administered through a face mask.remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
  • Active Comparator: remifentanil injected
    a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.
    Intervention: Drug: remifentanil injected
  • Active Comparator: sevoflurane in step up concentration
    a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
    Intervention: Drug: sevoflurane in step up concentration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2010
May 2010   (final data collection date for primary outcome measure)

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, pulmonary disease, gastric diseases, endocrinological diseases
  • recent use of psycho-active medication, including alcohol
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01103193
2009/493
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Hugo Vereecke, MD, PhD University Hospital, Ghent
University Hospital, Ghent
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP