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Clinical Trials/NCT00446212
NCT00446212CompletedPhase 4

Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

Melbourne Health4 sites in 2 countries300 target enrollmentStarted: August 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
300
Locations
4
Primary Endpoint
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire

Study Overview

Brief Summary

We hypothesise that patients who receive propofol for maintenance of anaesthesia will report dreaming more often when they emerge from anaesthesia than patients who receive desflurane for maintenance of anaesthesia.

Detailed Description

Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male and female patients
  • Age between 18 and 50 years
  • Presenting for elective surgery under general anaesthesia

Exclusion Criteria

  • Inadequate English language comprehension
  • Major drug abuse problem

Arms & Interventions

1

Active Comparator

Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics

Intervention: Propofol (Drug)

2

Active Comparator

Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics

Intervention: desflurane (Drug)

Outcomes

Primary Outcomes

Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire

Time Frame: recovery room stay

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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