ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000959077

Ethics application status

Approved

Date submitted

8/11/2010

Date registered

9/11/2010

Date last updated

9/11/2010

Type of registration

Prospectively registered

Titles & IDs

Public title

The influence of an intraoperative display of integrated drug kinetic, dynamic and interaction information on characteristics of patient recovery after anaesthesia and surgery.

Scientific title

To assess in patients undergoing surgery, the effect of a display of anaesthetic drug kinetic, dynamic and interaction information on recovery characteristics.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

The Effect of Integrated Drug Effect Displays in Anaesthesia
(EIDEDA)

Linked study record

Health condition

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

Anaesthetics
First-response time following surgery.

Post-surgery pain levels.

Quality of recovery following anaesthesia and surgery.

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients between 18 and 65 yrs requiring "Simple" laparoscopic surgery, e.g. laparoscopic cholecystectomy.
ASA 1, 2 or 3 with no contra-indications to study protocol.
Anaesthesia delivery guided by drug kinetic & interaction display. Expected duration of 12 months.

Intervention code [1]

Not applicable

Comparator / control treatment

In our study entitled 'To investigate the relationship between the invasiveness of surgery and the point at which patients awaken after anaesthesia and surgery' ACTRN12609001050246, we have been investigating the levels of sevoflurane at which patients waken from sevoflurane/fentanyl anaesthesia and the influence of age and surgical severity on these levels. One limb of this study involves patients between 18 and 65 yrs undergoing “simple” laparoscopic procedures. We have collected comprehensive data on the emergence and recovery period and plan to use this group as a basis for comparison with the study group in the new study.

Control group

Historical

Outcomes

Primary outcome [1]

Time from end of surgery to first response.

Timepoint [1]

Point at which patients regain consciousness as demonstrated by patient response to 'Open your eyes'command.

Secondary outcome [1]

Time to reach Post Anaesthetic Care Unit discharge criteria; worst pain score; total analgesic use in OT and PACU.
.

Timepoint [1]

PACU discharge time.

Secondary outcome [2]

Quality of Recovery score.

Timepoint [2]

Approximately 24-hrs after surgery.

Eligibility

Key inclusion criteria

Laparscopic cholecystectomy or similar 'level' laparoscopic procedure.
American Society of Anesthetists (ASA) 1, 2 or 3; Body Mass Index (BMI) less than 35.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Contra-indication to component of study protocol, Attending anaesthetist unwilling to follow protocol

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/11/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Christchurch Hospital -Deparmental resources & TrustFunds

Address [1]

Private Bage 4710, Rolleston Avenue, Christchurch 8140

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Christchurch Hospital - - Deparmental resources & Trust Funds

Address

Private Bage 4710, Rolleston Avenue, Christchurch 8140

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Upper South A Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
PO Box 3877
Christchurch

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

26/07/2010

Ethics approval number [1]

URA/10/06/042

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc Prof Dr Ross Kennedy/Margie McKellow

Address

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch

Country

New Zealand

Phone

+0064 3 3640288

Fax

+0064 3 3640289

[email protected]

Contact person for scientific queries

Name

Ross Kennedy

Address

Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch

Country

New Zealand

Phone

+0064 3 3640288

Fax

+0064 3 3640289

[email protected]

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically