Nitrous Oxide - Sevoflurane-Remifentanil Interaction

NCT01103193 | Terminated Phase 4

• 1 other identifier: 2009/493
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil

  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

  Every 12 minutes during induction and maintenance of anesthesia

Study Arms (2)

remifentanil injected

ACTIVE COMPARATOR

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

sevoflurane in step up concentration

ACTIVE COMPARATOR

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

Interventions

remifentanil injected DRUG

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.

remifentanil injected

sevoflurane in step up concentration DRUG

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.

sevoflurane in step up concentration

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Hugo Vereecke, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: April 14, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

BE (1)