Trial Review

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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?
Scientific title
The influence of antiemetic doses of dexamethasone on postoperative lymphocyte sub-populations after laparoscopic day-case gynaecological surgery
Secondary ID [1] 628 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative immune function 3345 0
Condition category
Condition code
Anaesthesiology 3500 3500 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone 4 mg or 8 mg given intravenously once at induction of anaesthesia
Intervention code [1] 3079 0
Treatment: Drugs
Comparator / control treatment
Active control (Droperidol 625 mcg) given intravenously once at the induction of anaesthesia
Control group
Active

Outcomes
Primary outcome [1] 4404 0
An alteration in T- and B-lymphocyte sub-populations as measured by blood sample analysis
Timepoint [1] 4404 0
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
Secondary outcome [1] 7539 0
Nil
Timepoint [1] 7539 0
N/A

Eligibility
Key inclusion criteria
Females undergoing day-case laparoscopic gynaecological 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 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

Study design
Purpose of the study
Educational / counselling / training
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
1/08/2008
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] 3540 0
Hospital
Name [1] 3540 0
Royal Perth Hospital
Country [1] 3540 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] 3179 0
Individual
Name [1] 3179 0
Dr Neil Muchatuta
Address [1] 3179 0
Dept of Anaesthesia and Pain Medicine,
King Edward Memorial Hospital for Women,
374 Bagot Road,
Subiaco,
WA 6008
Country [1] 3179 0
Australia
Other collaborator category [1] 323 0
Individual
Name [1] 323 0
Dr Tomas Corcoran
Address [1] 323 0
Department of Anaesthesia,
Royal Perth Hospital,
GPO Box Z2213,
Perth,
WA 6001
Country [1] 323 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5580 0
Ethics committee address [1] 5580 0
Ethics committee country [1] 5580 0
Date submitted for ethics approval [1] 5580 0
09/06/2008
Approval date [1] 5580 0
Ethics approval number [1] 5580 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 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28715 0
Address 28715 0
Country 28715 0
Phone 28715 0
Fax 28715 0
Email 28715 0
Contact person for public queries
Name 11872 0
Professor Michael Paech, Research Fellow, or Research Nurses
Address 11872 0
Dept of Anaesthesia and Pain Medicine,
King Edward memorial Hospital for Women,
374 Bagot Road,
Subiaco,
WA 6008
Country 11872 0
Australia
Phone 11872 0
08 9340 222 pager 3223 (Prof Paech), 3226 (Research Fellow), or 3433 (Research Nurses)
Fax 11872 0
08 9340 2260
Email 11872 0
Michael.Paech@health.wa.gov.au
Contact person for scientific queries
Name 2800 0
Dr Tomas Corcoran
Address 2800 0
Dept of Anaesthesia,
Royal Perth Hospital,
GPO Box Z2213,
Perth,
WA 6001
Country 2800 0
Australia
Phone 2800 0
08 9224 1038
Fax 2800 0
08 9224 1111
Email 2800 0
Tomas.Corcoran@health.wa.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseIntraoperative dexamethasone alters immune cell populations in patients undergoing elective laparoscopic gynaecological surgery.2017https://dx.doi.org/10.1093/bja/aex154
N.B. These documents automatically identified may not have been verified by the study sponsor.