Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depth of Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

0 ng/ml target effect site concentration remifentanil

Group Type PLACEBO_COMPARATOR

remifentanil

Intervention Type DRUG

target effect site concentration during induction

2

2 ng/ml target concentration remifentanil

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

target effect site concentration during induction

3

4 ng/ml target effect site concentration remifentanil

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

target effect site concentration during induction

Interventions

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remifentanil

target effect site concentration during induction

Intervention Type DRUG

Other Intervention Names

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No other names

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No