Nitrous Oxide - Sevoflurane-Remifentanil Interaction
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia
Intervention: remifentanil injected (Drug); sevoflurane in step up concentration (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Hugo Vereecke, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital Ghent, Ghent, Belgium
Additional Information
website University Hospital Ghent
Starting date: February 2010
Last updated: May 7, 2012
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