Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001050246
Ethics application status
Approved
Date submitted
2/12/2009
Date registered
8/12/2009
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of surgery on sevoflurane brain levels and awakening after anaesthesia.
Scientific title
To investigate the relationship between the invasiveness of surgery and the point at which patients awaken after anaesthesia and surgery.
Secondary ID [1] 1178 0
Nil
Universal Trial Number (UTN)
Trial acronym
SW Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetics 252220 0
First-response time following surgery. 252360 0
Gall bladder problems 252362 0
Bowel conditions 252363 0
Condition category
Condition code
Anaesthesiology 252239 252239 0 0
Anaesthetics
Surgery 256547 256547 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
major bowel surgery and "simple" laparoscopic surgery -determining time of first-response after surgery, pain scores in Post Anaesthetic Care Unit (PACU), time to reach PACU discharge criteria, recovery score. Observed, when possible, up to 48 or 76 hrs post-surgery.
Intervention code [1] 241446 0
Not applicable
Comparator / control treatment
Two surgical groups:
1. Intermediate surgery ('simple laparoscopic surgery)
2. Major surgery - major bowel surgery/liver resections & surgery of similar 'invasiveness'
Control group
Active

Outcomes
Primary outcome [1] 253113 0
Sevoflurane & fentanyl levels in blood and effect site.
Timepoint [1] 253113 0
First response (time of patient response to 'open-eye' command) post operatively
Secondary outcome [1] 257983 0
Worst post-operative pain score in recovery as assessed on the standard 0-5 scale (where 0=no pain & 5=extreme pain) routinely used in PACU.
Timepoint [1] 257983 0
Prior to discharge from Recovery.
Secondary outcome [2] 257989 0
Quality of Recovery score .
Timepoint [2] 257989 0
Prior to discharge from hospital.

Eligibility
Key inclusion criteria
Non-emergency surgery
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 propofol.
Contra-indication to sevoflurane.
Contra-indication to fentanyl.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment outside Australia
Country [1] 2272 0
New Zealand
State/province [1] 2272 0

Funding & Sponsors
Funding source category [1] 256120 0
Self funded/Unfunded
Name [1] 256120 0
Country [1] 256120 0
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Private Bage 4710
Rolleston Ave
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 251464 0
None
Name [1] 251464 0
Address [1] 251464 0
Country [1] 251464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244032 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 244032 0
C/- Ministry of Health
4th floor
250 Oxford Terrace
PO Box 3877
Christchurch 8140
Ethics committee country [1] 244032 0
New Zealand
Date submitted for ethics approval [1] 244032 0
Approval date [1] 244032 0
06/05/2009
Ethics approval number [1] 244032 0
URB/08/05/025

Summary
Brief summary
Previous audit data has suggested the magnitude of surgery has an influence on calculated effect site sevoflurane levels at awakening. The aim of this study is to evaluate this difference using a structured anaesthetic technique so as to minimise confounding variables. As intrathecal morphine (ITM) has become a common adjunct in major surgery we are also exploring the effect of ITM on effect site sevoflurane
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30402 0
Address 30402 0
Country 30402 0
Phone 30402 0
Fax 30402 0
Email 30402 0
Contact person for public queries
Name 13649 0
Margie McKellow
Address 13649 0
c/o Department of Anaesthesia
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country 13649 0
New Zealand
Phone 13649 0
+64 3 3640288
Fax 13649 0
+64 3 3640289
Email 13649 0
margie.mckellow@cdhb.govt.nz
Contact person for scientific queries
Name 4577 0
Assoc Prof Ross Kennedy
Address 4577 0
c/o Department of Anaesthesia
Christchurch Hospital
2 Riccarton Avenue
Private Bag 4710
Christchurch 8011
Country 4577 0
New Zealand
Phone 4577 0
+64 3 3640288
Fax 4577 0
+64 3 3640289
Email 4577 0
ross.kennedy@otago.ac.nz

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
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