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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] 251948 0
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. 257519 0
Post-surgery pain levels. 257520 0
Quality of recovery following anaesthesia and surgery. 258615 0
Condition category
Condition code
Anaesthesiology 257681 257681 0 0
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] 256617 0
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] 258586 0
Time from end of surgery to first response.
Timepoint [1] 258586 0
Point at which patients regain consciousness as demonstrated by patient response to 'Open your eyes'command.
Secondary outcome [1] 264475 0
Time to reach Post Anaesthetic Care Unit discharge criteria; worst pain score; total analgesic use in OT and PACU.
.
Timepoint [1] 264475 0
PACU discharge time.
Secondary outcome [2] 264476 0
Quality of Recovery score.
Timepoint [2] 264476 0
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?
No
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
33
Accrual to date
Final
Recruitment outside Australia
Country [1] 2682 0
New Zealand
State/province [1] 2682 0
Canterbury

Funding & Sponsors
Funding source category [1] 257106 0
Hospital
Name [1] 257106 0
Christchurch Hospital -Deparmental resources & TrustFunds
Country [1] 257106 0
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] 256368 0
None
Name [1] 256368 0
Address [1] 256368 0
Country [1] 256368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260010 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 260010 0
Ministry of Health
PO Box 3877
Christchurch
Ethics committee country [1] 260010 0
New Zealand
Date submitted for ethics approval [1] 260010 0
Approval date [1] 260010 0
26/07/2010
Ethics approval number [1] 260010 0
URA/10/06/042

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31261 0
Address 31261 0
Country 31261 0
Phone 31261 0
Fax 31261 0
Email 31261 0
Contact person for public queries
Name 14508 0
Assoc Prof Dr Ross Kennedy/Margie McKellow
Address 14508 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch
Country 14508 0
New Zealand
Phone 14508 0
+0064 3 3640288
Fax 14508 0
+0064 3 3640289
Email 14508 0
[email protected]
Contact person for scientific queries
Name 5436 0
Ross Kennedy
Address 5436 0
Department of Anaesthesia
Christchurch Hospital
Private Bag 4710
Christchurch
Country 5436 0
New Zealand
Phone 5436 0
+0064 3 3640288
Fax 5436 0
+0064 3 3640289
Email 5436 0
[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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo

Documents added automatically
No additional documents have been identified.