Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000497303
Ethics application status
Not yet submitted
Date submitted
30/07/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Steroids prevent nausea and vomiting after open gynaecological surgery, but do they harm the immune system?
Scientific title
The influence of antiemetic doses of dexamethasone on postoperative lymphocyte sub-populations after open gynaecological surgery
Secondary ID [1] 655 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative immune function 3485 0
Condition category
Condition code
Anaesthesiology 3641 3641 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone 4 mg or 8 mg (as determined by randomisation sequence)given intravenously once at induction of anaesthesia
Intervention code [1] 3209 0
Treatment: Drugs
Comparator / control treatment
Active control (Droperidol 625 mcg) given intravenously once at the induction of anaesthesia. Single dose only
Control group
Active

Outcomes
Primary outcome [1] 4539 0
An alteration in T- and B-lymphocyte sub-populations as measured by blood sample analysis
Timepoint [1] 4539 0
Preoperative; 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 96 hours postoperatively, and one blood test taken between 4 and 6 weeks postoperatively
Secondary outcome [1] 7686 0
None
Timepoint [1] 7686 0
None

Eligibility
Key inclusion criteria
Females undergoing open gynaecologic surgery
American Society of Anesthesiologists (ASA) classification 1-3 patients
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current drug therapy with antiemetic or systemic steroidal activity
Known or suspected metastatic disease
Recent treatment with chemotherapeutic agents
Patients involving implants, such as mesh repairs
Opioid-tolerance
Hypertension
Diabetes mellitus
Peptic ulceration
Intolerance to non-steroidal anti-inflammatory drugs
Hypersensitivity to dexamethasone, granisetron or droperidol

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations will be concealed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3662 0
Hospital
Name [1] 3662 0
Royal Perth Hospital
Country [1] 3662 0
Australia
Primary sponsor type
Individual
Name
Professor Michael Paech
Address
Dept of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 3290 0
Individual
Name [1] 3290 0
Dr Neil Muchatuta
Address [1] 3290 0
Dept of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco, WA 6008
Country [1] 3290 0
Australia
Other collaborator category [1] 351 0
Individual
Name [1] 351 0
Dr Tomas Corcoran
Address [1] 351 0
Dept of Anaesthesia
Royal Perth Hospital
GPO Box Z2213
Perth, WA 6001
Country [1] 351 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5716 0
Ethics committee address [1] 5716 0
Ethics committee country [1] 5716 0
Date submitted for ethics approval [1] 5716 0
09/06/2008
Approval date [1] 5716 0
Ethics approval number [1] 5716 0

Summary
Brief summary
Postoperative nausea and vomiting remains a significant problem in modern anaesthetic practice. One of the most effective anti-sickness agents (antiemetics) available is a steroid drug: dexamethasone. Steroids are also used to supress the immune system and inflammation in the body. This immune supression can also predispose to the development of infection. We wish to investigate whether the small doses of dexamethasone used in anaesthesia affects the nature and function of important immune system cells known as lymphocytes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28793 0
Address 28793 0
Country 28793 0
Phone 28793 0
Fax 28793 0
Email 28793 0
Contact person for public queries
Name 11950 0
Professor Michael Paech, Research Fellow, or Research Nurses
Address 11950 0
Dept of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco, WA 6008
Country 11950 0
Australia
Phone 11950 0
09 9340 2222 pager 3223 (Prof Paech), 3226 (Reasearch Fellow), or 3433 (Research Nurses)
Fax 11950 0
08 9340 2260
Email 11950 0
[email protected]
Contact person for scientific queries
Name 2878 0
Dr Tomas Corcoran
Address 2878 0
Dept of Anaesthesia
Royal Perth Hospital
GPO Box Z2213
Perth, WA 6001
Country 2878 0
Australia
Phone 2878 0
08 9224 1038
Fax 2878 0
08 9224 1111
Email 2878 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.