Nitrous Oxide - Sevoflurane-Remifentanil Interaction
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia |
Drug: remifentanil injected Drug: sevoflurane in step up concentration |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: 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. |
- 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
| Enrollment: | 4 |
| Study Start Date: | February 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01103193 History of Changes |
| Other Study ID Numbers: | 2009/493 |
| Study First Received: | March 19, 2010 |
| Last Updated: | May 7, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
ASA class I/II patients, with surgery under general anesthesia |
Additional relevant MeSH terms:
|
Nitrous Oxide Sevoflurane Remifentanil Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Platelet Aggregation Inhibitors Hematologic Agents Analgesics, Opioid Hypnotics and Sedatives Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on May 19, 2013