The Perioperative Administration of Dexamethasone and Glucose concentrations in diabetic and non-diabetic surgical patients

In diabetic and non-diabetic surgical patients, does the administration of perioperative dexamethasone compared to placebo, increase blood glucose concentrations

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001145695

Acronym

PADDAG

Enrollment

286

Registered

2014-10-29

Start date

2015-03-01

Completion date

2016-06-06

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

Pure regional anaesthesia Hypersensitivity to study drug Poorly controlled Type 1 diabetes mellitus Sickle cell anaemia Thalassemia 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

Outcome results