Observational, prospective drug administration and physiological data collection during anaesthesia
Not Applicable
Completed
- Conditions
- Validation of current response surface models (for anaesthetic drug interactions) available in the literatureAnaesthesiology - Other anaesthesiology
- Registration Number
- ACTRN12610000277044
- Lead Sponsor
- Department of Anaesthesiology, University of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Patients receiving general anaesthesia from six demographic groups will be studied:
* Healthy Adults: 18 - 65 years; body mass index 18.5 - 25 (as defined by the World Health Organisation)
* Cardiac bypass patients
* Elderly, defined as age > 70 years
* Overweight, body mass index > 30
* Those who receive total intravenous anaesthesia
* American Society of Anesthesiologists (ASA) grade 3-4 patients undergoing emergency surgery
Exclusion Criteria
Patients with neurological dysfunction, head trauma, opioid dependence and renal or hepatic co-morbidities will not be studied
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The data will be used to evaluate the current response surface models available in the literature, pertaining to drug effect as measured by Bispectral Index Monitoring (BIS). Drug administrations observed in the clinical data will be used as model inputs, and predicted BIS outputs calculated. Predicted BIS will be compared with observed BIS (from the clinical data). <br>Measures of model performance will include predictive performance (BISobserved - BISpredicted) x 100) , bias and inaccuracy. Diagnostic plots (including predicted and observed effects over time) will also be used to evaluate model performance.[Evaluation of models will be performed upon completion of data collection from 160 anaesthetic cases at Auckland City Hospital. We expect this will be fully completed April 2012]
- Secondary Outcome Measures
Name Time Method il[N/A]