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Trial registered on ANZCTR
Registration number
ACTRN12608000340336
Ethics application status
Not yet submitted
Date submitted
30/06/2008
Date registered
18/07/2008
Date last updated
18/07/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Steroids prevent nausea and vomiting after day-case surgery, but do they harm the immune system?
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Scientific title
The influence of antiemetic doses of dexamethasone on postoperative lymphocyte sub-populations after laparoscopic day-case gynaecological surgery
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Secondary ID [1]
628
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative immune function
3345
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Condition category
Condition code
Anaesthesiology
3500
3500
0
0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dexamethasone 4 mg or 8 mg given intravenously once at induction of anaesthesia
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Intervention code [1]
3079
0
Treatment: Drugs
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Comparator / control treatment
Active control (Droperidol 625 mcg) given intravenously once at the induction of anaesthesia
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Control group
Active
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Outcomes
Primary outcome [1]
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An alteration in T- and B-lymphocyte sub-populations as measured by blood sample analysis
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Assessment method [1]
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Timepoint [1]
4404
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Preoperative; 4 hours postoperatively, one blood test taken between 4 and 7 days postoperatively, and one blood test taken between 4 and 6 weeks postoperatively
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Secondary outcome [1]
7539
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Nil
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Assessment method [1]
7539
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Timepoint [1]
7539
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N/A
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Eligibility
Key inclusion criteria
Females undergoing day-case laparoscopic gynaecological surgery.
American Society of Anesthesiologists (ASA) classification 1-3 patients
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Current drug therapry with drugs with antiemetic or systemic steroidal activity.
Known or suspected malignancy.
Patients receiving implants such as mesh repairs.
Opioid-tolerence.
Hypertension.
Diabetes mellitus.
Peptic ulceration.
Intolerence to non-steroidal anti-inflammatory drugs.
Hypersensitivity to dexathethasone, granisetron or droperidol
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations will be concealed in sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
3540
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Hospital
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Name [1]
3540
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Royal Perth Hospital
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Address [1]
3540
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Department of Anaesthesia,
Royal Perth Hospital,
GPO Box Z2213,
Perth,
WA 6001
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Country [1]
3540
0
Australia
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Primary sponsor type
Individual
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Name
Professor Michael Paech
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Address
Dept of Anaesthesia and Pain Medicine,
King Edward Memorial Hospital for Women,
374 Bagot Road,
Subiaco,
WA 6008
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Country
Australia
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Secondary sponsor category [1]
3179
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Individual
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Name [1]
3179
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Dr Neil Muchatuta
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Address [1]
3179
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Dept of Anaesthesia and Pain Medicine,
King Edward Memorial Hospital for Women,
374 Bagot Road,
Subiaco,
WA 6008
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Country [1]
3179
0
Australia
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Other collaborator category [1]
323
0
Individual
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Name [1]
323
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Dr Tomas Corcoran
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Address [1]
323
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Department of Anaesthesia,
Royal Perth Hospital,
GPO Box Z2213,
Perth,
WA 6001
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Country [1]
323
0
Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
5580
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Ethics committee address [1]
5580
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Ethics committee country [1]
5580
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Date submitted for ethics approval [1]
5580
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09/06/2008
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Approval date [1]
5580
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Ethics approval number [1]
5580
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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 suppress 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
28715
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Country
28715
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Phone
28715
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Fax
28715
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Email
28715
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Contact person for public queries
Name
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Professor Michael Paech, Research Fellow, or Research Nurses
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Address
11872
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Dept of Anaesthesia and Pain Medicine,
King Edward memorial Hospital for Women,
374 Bagot Road,
Subiaco,
WA 6008
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Country
11872
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Australia
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Phone
11872
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08 9340 222 pager 3223 (Prof Paech), 3226 (Research Fellow), or 3433 (Research Nurses)
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Fax
11872
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08 9340 2260
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Email
11872
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[email protected]
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Contact person for scientific queries
Name
2800
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Dr Tomas Corcoran
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Address
2800
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Dept of Anaesthesia,
Royal Perth Hospital,
GPO Box Z2213,
Perth,
WA 6001
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Country
2800
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Australia
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Phone
2800
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08 9224 1038
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Fax
2800
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08 9224 1111
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Email
2800
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[email protected]
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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
Embase
Intraoperative dexamethasone alters immune cell populations in patients undergoing elective laparoscopic gynaecological surgery.
2017
https://dx.doi.org/10.1093/bja/aex154
N.B. These documents automatically identified may not have been verified by the study sponsor.
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