Nitrous Oxide - Sevoflurane-Remifentanil Interaction

Sponsor

University Hospital, Ghent (Other)

Overall Status

Terminated

CT.gov ID

NCT01103193

Collaborator

(none)

Enrollment

Location

Arms

2.9

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia	Drug: remifentanil injected Drug: sevoflurane in step up concentration	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil [Every 12 minutes during induction and maintenance of anesthesia]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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, pulmonary disease, gastric diseases, endocrinological diseases
recent use of psycho-active medication, including alcohol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Hugo Vereecke, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

website University Hospital Ghent

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01103193

Other Study ID Numbers:

2009/493

First Posted:

Apr 14, 2010

Last Update Posted:

May 8, 2012

Last Verified:

May 1, 2012

Keywords provided by University Hospital, Ghent

ASA class I/II patients, with surgery under general anesthesia

Additional relevant MeSH terms:

Remifentanil

Sevoflurane

Study Results

No Results Posted as of May 8, 2012