Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Depth of Anaesthesia Clinical Trial

Official title:

Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455026
• Other study ID #: 2005.236
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2007
• Last updated: May 28, 2013
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2007
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.

Description:

Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia

Exclusion Criteria:

• Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability

• Epilepsy or other EEG abnormality

• Prescription or illicit drugs known to affect the EEG

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depth of Anaesthesia

Intervention

Drug:
• remifentanil
target effect site concentration during induction

Locations

Country	Name	City	State
Australia	Swinburne University	Hawthorn	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	Biopharmica Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction probability for prediction of anaesthetic endpoints		During induction of anaesthesia	No