ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000279527

Ethics application status

Approved

Date submitted

28/06/2006

Date registered

4/07/2006

Date last updated

26/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Dreaming and EEG changes during anaesthesia maintained with propofol or desflurane

Scientific title

The incidence of dreaming and the nature of electroencephalographic (EEG) changes during anaesthesia maintained with propofol or desflurane

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

GENIE II

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dreaming during anaesthesia

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Control = continuous intravenous propofol infusion for maintenance of anaesthesia. Duration of administration and total dose will depend on duration of surgery.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Comparison = continuous inhaled desflurane for maintenance of anaesthesia. Duration of administration and total dose will depend on duration of surgery.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of dreaming during anaesthesia as evidence by self-report

Timepoint [1]

At an immediate postoperative interview

Secondary outcome [1]

Times to eye open

Timepoint [1]

After cessation of anaesthetic administration, patients may first spontaneously open their eyes while they are still on the operating theatre or may not open their eyes until they are in the recovery room. Whenever the patient first opens their eyes, this will be recorded. This endpoint only happens once.

Secondary outcome [2]

Orientation and recovery room discharge

Timepoint [2]

Every 2 min after the patient opens their eyes they are assessed for orientation to time place and person. This endpoint will be recorded once only, on the first occasion that the patient is orientated. The time of recovery room discharge will be recorded once, when the patient leaves the recovery room.

Secondary outcome [3]

EEG variables during maintenance of anaesthesia and during recovery.

Timepoint [3]

Continuously during maintenance and recovery (data points every 1 min)

Eligibility

Key inclusion criteria

Presenting for relaxant general anaesthesia for non-cardiac surgery. Expected to be available for immediate postoperative interview.

Minimum age

18 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with inadequate English language comprehension or major drug abuse problems.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will be concealed in opaque envelopes until consent has been obtained

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2006

Actual

16/08/2006

Date of last participant enrolment

Anticipated

Actual

1/02/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

300

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

630 St Kilda Rd, Melbourne, VIC, 3004

Country [1]

Australia

Primary sponsor type

Individual

Name

Associate Professor Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville Victoria 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Hospital

Ethics committee address [1]

Parkville, VIC, 3050.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/08/2006

Ethics approval number [1]

2006.125

Ethics committee name [2]

Royal Perth Hospital

Ethics committee address [2]

Perth, WA, 6000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

King Edward Hospital for Women

Ethics committee address [3]

Subiaco, WA

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Waikato Hospital

Ethics committee address [4]

Hamilton, New Zealand

Ethics committee country [4]

New Zealand

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Summary

Brief summary

Dreaming is commonly reported after anaesthesia. There is some evidence that dreaming is more likely to be reported after anaesthesia maintained with propofol than anaesthesia maintained with desflurane. In this study, we will randomise patients having non-cardiac surgery to anaesthesia with propofol or desflurane and will measure the incidence of dreaming. Post-operative observers will be blind to group allocation (propofol or desflurane)

Trial website

Trial related presentations / publications

LESLIE K, Sleigh J, Paech M, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology 2009; 111:547-55

Public notes

Contacts

Principal investigator

Name

Prof Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia

Country

Australia

Phone

+61-3-93427540

Fax

kate.leslie@mh.org.au

Contact person for public queries

Name

Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050

Country

Australia

Phone

+61 3 93427540

Fax

+61 3 93428623

kate.leslie@mh.org.au

Contact person for scientific queries

Name

Kate Leslie

Address

Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050

Country

Australia

Phone

+61 3 93427540

Fax

+61 3 93428623

kate.leslie@mh.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Detection of Burst Suppression Patterns in EEG Using Recurrence Rate	2014	https://doi.org/10.1155/2014/295070

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically