Anesthesia Clinical Trial
— WalibiOfficial title:
Walking the Isobole of Drug Interaction: Comparison of Hemodynamic Effects, Cerebral and Tissue Oxygenation for 4 Equipotent Combinations of Propofol and Remifentanil
The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.
Status | Completed |
Enrollment | 87 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - General anesthesia required for the procedure - Age: 18 years and older - American Society of Anesthesiologists (ASA) physical status I to III Exclusion Criteria: - Refusal to participate in this study - Contra-indications for the use of propofol or remifentanil - BMI > 35 kg/m2 - Central nervous system disorders (i.e. cerebrovascular accident, dementia, seizures, psychiatric disorders) - Relevant hepatic disease (Child B or higher) - Regular use of medication that affects the central nervous system (i.e. benzodiazepines, antidepressants, antipsychotics, antiepileptic drugs) - Use of alpha-agonists or beta-blockers - Overt signs of alcohol abuse - Use of preoperative benzodiazepines (on the day of the study) - Beta blockers eye drips - Overt signs of Drugs abuse |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure | Continuously stored on a laptop (systolic, diastolic and mean blood pressure over time) using a Philips Non Invasive Blood Pressure measurements every minute and a Nexfin monitor (continuous non invasive blood pressure measurement) | From start drug till intubation which will take on average 15 minutes of measurement | Yes |
Secondary | Electro Encephalographic derived indices of anesthetic depth | Bispectral index, Wavelet Transformation (WAV) index, Quantium Consciousness Index (qCON), Quantium Nociception Index (qNOX) to observe whether multiple electroencephalographic derived depth of anesthesia indices indicate the same equipotent effect in all 4 groups. All these measures are unitless values that range between 100 (for a fully responsive condition) and 0 (for a fully unresponsive condition). All these measures are extracted from the same frontal electroencephalogram but use different composite mathematical algorithms to translate the cortical state in numbers. We want to observe whether these composite algorithms measure consistent behavior between groups. This outcome is mainly ment as hypothesis generating for future research. | From start first drug till intubation, which will take on average 15 minutes of measurement | No |
Secondary | Cerebral and tissue oxygenation | Continuously stored oxygenation saturation measured in tissue and cerebral cortex as measured by Near Infrared Spectrum Analysis (Forsyth monitor) and Inspectra monitor. Comparing differences between 4 groups with ANOVA. | From start drug till intubation, which will take on average 15 minutes of measurement | Yes |
Secondary | Heart rate | Difference in median/mean heart rate to determine differences between 4 groups with ANOVA. | From start first drug till intubation, which will take on average 15 minutes of measurement | Yes |
Secondary | Probability of tolerance to laryngoscopy | During pharmacological steady state of propofol/remifentanil, a laryngoscopy will be performed by one researcher and response or tolerance of the stimulus will be observed. A positive response will be defined as any somatic movement, swallowing or coughing during three minutes after laryngoscopy was applied. Also a increase in heart rate or systolic blood pressure of more than 20% from baseline values (one minute before laryngoscopy) will be defined as a positive response. Through PROBIT analysis we can plot the probability of response to laryngoscopy (%) as a function of respectively propofol or remifentanil drug concentrations. | one minute before laryngoscopy till three minutes after | No |
Secondary | Cardiac index | Non invasive estimation of Cardiac output and Cardiac index patterns through the Nexfin monitor. Determine the differences between groups through ANOVA. | From start first drug till intubation, which will take on average 15 minutes of measurement | Yes |
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