Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000406404
Ethics application status
Not yet submitted
Date submitted
2/08/2007
Date registered
7/08/2007
Date last updated
7/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Does dexamethasone influence blood cortisol levels after laparoscopic cholecystectomy?
Scientific title
Dexamethasone administration for postoperative nausea and vomiting in laparoscopic cholecystectomy and perioperative cortisol levels.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic cholecystectomy 2210 0
Gallstone disease 2211 0
Cholecystitis 2212 0
Postoperative nausea and vomiting 2213 0
Postoperative pain 2214 0
Condition category
Condition code
Oral and Gastrointestinal 2305 2305 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone 8mg once only intravenously at commencement of anaesthesia for laparoscopic cholecystectomy. All participants (both active and control groups) receive tropisetron 2mg intravenously at the completion of surgery. Dexamethasone and tropisetron are used to prevent postoperative nausea and vomiting.
Intervention code [1] 1925 0
Treatment: Drugs
Comparator / control treatment
The placebo is 2ml of normal saline given once only at induction of anaesthesia.
Control group
Placebo

Outcomes
Primary outcome [1] 3200 0
Perioperative cortisol levels
Timepoint [1] 3200 0
Measured immediately preoperatively, 20 minutes after administration of dexamethasone and 8 hours postoperatively.
Secondary outcome [1] 5337 0
Pain scores using visual analgogue scale (VAS) or numeric rating scale (NRS).
Timepoint [1] 5337 0
These endpoints will be measured twice daily on the operative day and for 2 days postoperatively.
Secondary outcome [2] 5338 0
Episodes of nausea
Timepoint [2] 5338 0
These endpoints will be measured twice daily on the operative day and for 2 days postoperatively.
Secondary outcome [3] 5339 0
Episodes of vomiting
Timepoint [3] 5339 0
These endpoints will be measured twice daily on the operative day and for 2 days postoperatively.
Secondary outcome [4] 5340 0
Analgesia and antiemetic use
Timepoint [4] 5340 0
These endpoints will be measured twice daily on the operative day and for 2 days postoperatively.

Eligibility
Key inclusion criteria
Patients undergoing laparoscopic cholecystectomy with none of the exclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speakingInsulin requiring diabetesPatients receiving exogenous steroid treatment for other illness.Unable to receive standardised inhalational anaesthesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes opened at the time of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subjects, clinician administering the drug and the assessors will be blinded.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2471 0
Hospital
Name [1] 2471 0
Department of Anaesthesia
St Vincents Health
Country [1] 2471 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Health Melbourne
Address
Country
Australia
Secondary sponsor category [1] 2244 0
None
Name [1] 2244 0
No secondary sponsor
Address [1] 2244 0
Country [1] 2244 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4348 0
St Vincents Health Melbourne
Ethics committee address [1] 4348 0
Melbourne VIC
Ethics committee country [1] 4348 0
Australia
Date submitted for ethics approval [1] 4348 0
Approval date [1] 4348 0
Ethics approval number [1] 4348 0

Summary
Brief summary
The primary endpoint of the study is to determine if dexamethasone 8mg, administered at the start of an anaesthetic to prevent postoperative nausea and vomiting, reduces the level of cortisol postoperatively. Cortisol is a hormone produced by the adrenal glands in times of stress (such as at operation). Dexamethasone is frequently used to prevent nausea and vomiting after operations and is known to reduce cortisol levels in patients not having operations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27739 0
Address 27739 0
Country 27739 0
Phone 27739 0
Fax 27739 0
Email 27739 0
Contact person for public queries
Name 11114 0
Dr Kara Allen
Address 11114 0
Department of Anaesthesia
St Vincent's Hospital
PO Box 2900
Melbourne
Fitzroy VIC 3065
Country 11114 0
Australia
Phone 11114 0
+61 3 92884253
Fax 11114 0
Email 11114 0
[email protected]
Contact person for scientific queries
Name 2042 0
Dr Kara Allen
Address 2042 0
Department of Anaesthesia
St Vincent's Hospital
PO Box 2900
Melbourne
Fitzroy VIC 3065
Country 2042 0
Australia
Phone 2042 0
+61 3 92884253
Fax 2042 0
Email 2042 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.