NCT00446212

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

March 8, 2007

Last Update Submit

May 28, 2013

Conditions

Keywords

anaesthesiapropofoldesfluranedreamingelectroencephalography

Outcome Measures

Primary Outcomes (1)

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

    recovery room stay

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Propofol

2

ACTIVE COMPARATOR

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

Drug: desflurane

Interventions

target controlled infusion of propofol

1

Anaesthetic maintenance with desflurane

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inadequate English language comprehension
  • Major drug abuse problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

King Edward Memorial Hospital for Women

Subiaco, Western Australia, 6008, Australia

Location

Waikato Hospital

Hamilton, New Zealand

Location

Related Publications (2)

  • Liang Z, Wang Y, Ren Y, Li D, Voss L, Sleigh J, Li X. Detection of burst suppression patterns in EEG using recurrence rate. ScientificWorldJournal. 2014;2014:295070. doi: 10.1155/2014/295070. Epub 2014 Apr 17.

  • Leslie K, Sleigh J, Paech MJ, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology. 2009 Sep;111(3):547-55. doi: 10.1097/ALN.0b013e3181adf768.

MeSH Terms

Interventions

PropofolDesflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Kate Leslie, MD

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 12, 2007

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations