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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
The Perioperative Administration of Dexamethasone and Glucose concentrations in diabetic and non-diabetic surgical patients
Scientific title
In diabetic and non-diabetic surgical patients, does the administration of perioperative dexamethasone compared to placebo, increase blood glucose concentrations
Secondary ID [1] 285510 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 293306 0
Surgery 293307 0
Condition category
Condition code
Anaesthesiology 293579 293579 0 0
Metabolic and Endocrine 293616 293616 0 0
Surgery 293617 293617 0 0
Other surgery

Study type
Description of intervention(s) / exposure
Random allocation to either Placebo, Dexamethasone 4mg or 8mg IV at induction of anaesthesia, within EACH of two strata ( diabetic or non-diabetic )This will be determined according to their know diabetic status. The allocation will be by the use of a random number generator
Intervention code [1] 290450 0
Treatment: Drugs
Comparator / control treatment
Placebo ( intravenous saline bolus )
Control group

Primary outcome [1] 293392 0
Peak postoperative blood glucose concentrations
Timepoint [1] 293392 0
Hourly intraoperatively, and up to 6 hourly postoperaively up to 24 hours
Secondary outcome [1] 310920 0
Surgical site infection as determined by microbiological culture or the use of antibiotics
Timepoint [1] 310920 0
30 days postoperatively
Secondary outcome [2] 310921 0
Postoperative nausea and vomiting as determined with a Verbal Response Scale
Timepoint [2] 310921 0
24 hours postoperatively
Secondary outcome [3] 310922 0
Acute Pain as determined with a Verbal Response Scale (VRS)
Timepoint [3] 310922 0
24 hours postoperatively
Secondary outcome [4] 310923 0
Quality of Recovery (QOR) using the QOR-15 tool
Timepoint [4] 310923 0
30 days
Secondary outcome [5] 310924 0
Disability [WHODAS]
Timepoint [5] 310924 0
One year
Secondary outcome [6] 310925 0
Chronic post-surgical pain using the mBPI and Neuropathic pain questionnaire
Timepoint [6] 310925 0
One year
Secondary outcome [7] 310926 0
Surgical Complications [Dindo-CLavien grade]
Timepoint [7] 310926 0
30 days
Secondary outcome [8] 310927 0
Length of hospital stay
Timepoint [8] 310927 0
Until discharged postoperatively
Secondary outcome [9] 310928 0
Sepsis using the Surviving Sepsis Guidelines and CDC criteria
Timepoint [9] 310928 0
30 days

Key inclusion criteria
Elective surgical patients
Skin incision required
Surgical duration greater than one hour
At least one night hospital stay postoperatively
General anaesthesia
ASA grade 1-4
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Pure regional anaesthesia
Hypersensitivity to study drug
Poorly controlled Type 1 diabetes mellitus
Sickle cell anaemia
Surgical procedure within the previous 3 months
Surgical procedure planned within 30 days of the index procedure
Infection within three months prior to procedure
Maxillofacial surgery
Intraoperative requirement
Renal Impairment
Immunosuppressive therapy or state
Concurrent systemic glucocorticoid usage
Moderate or severe liver disease
Metastatic cancer
Opthalmic surgery
Endovascular procedures

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratification according to presence or absence of diabetes
Double blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was conducted using permuted blocks, with stratification according to site to ensure balance across the strata at each site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis
Superiority design
We will need to recruit 112 experimental subjects and 112 control subjects, in each stratum ( diabetic and non-diabetic) , to be able to reject the null hypothesis with a Type I error of 0.05 and power of 0.8. Total cohort = 112 x 6 = 672. We will recruit 700 patients allowing for a dropout rate of 2.5%.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3051 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 3052 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 8834 0
6000 - Perth
Recruitment postcode(s) [2] 8835 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 290107 0
Name [1] 290107 0
Medical Research Foundation
Address [1] 290107 0
Royal Perth Hospital
Box X2213
GPO Perth 6847
Western Australia
Country [1] 290107 0
Primary sponsor type
Royal Perth Hospital
Wellington Street
Perth City
Western Australia
WA 6000
Secondary sponsor category [1] 288843 0
Name [1] 288843 0
Address [1] 288843 0
Country [1] 288843 0

Ethics approval
Ethics application status
Ethics committee name [1] 291816 0
Fremantle Hospital Ethics Committee
Ethics committee address [1] 291816 0
Alma Street
Western Australia
Ethics committee country [1] 291816 0
Date submitted for ethics approval [1] 291816 0
Approval date [1] 291816 0
Ethics approval number [1] 291816 0

Brief summary
The proposed PADDAG trial is a prospective, stratified-randomised controlled trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in adult surgical patients, is associated with an increased blood glucose concentration, and whether this increase is greater in patients with diabetes than in those without. Secondary outcomes will include the risk of infection, and the interaction between dexamethasone administration, diabetic status, glycaemic control and infective complications.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 52146 0
Prof Tomas Corcoran
Address 52146 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
WA, 6000
Country 52146 0
Phone 52146 0
Fax 52146 0
Email 52146 0
Contact person for public queries
Name 52147 0
Mrs Pauline Coutts
Address 52147 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
WA, 6000
Country 52147 0
Phone 52147 0
Fax 52147 0
Email 52147 0
Contact person for scientific queries
Name 52148 0
Prof Tomas Corcoran
Address 52148 0
Department of Anaesthesia and Pain Medicine
Level 4, North Block
Royal Perth Hospital
Wellington Street
WA, 6000
Country 52148 0
Phone 52148 0
Fax 52148 0
Email 52148 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary