Abstract
INTRODUCTION: The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications. METHODS/ANALYSIS: This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria. ETHICS/DISSEMINATION: The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020. TRIAL REGISTRATION NUMBER: ACTRN12614001226695.
| Original language | English |
|---|---|
| Article number | e030402 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Volume | 9 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 6 Sep 2019 |
Keywords
- Dexamethasone
- Diabetes
- glucocorticoid
- Postoperative Nausea and Vomiting
- Surgical Wound Infection
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The perioperative administration of dexamethasone and infection (PADDI) trial protocol : rationale and design of a pragmatic multicentre non-inferiority study. / Corcoran, Tomás B.; Myles, Paul S.; Forbes, Andrew B.; O'Loughlin, Ed; Leslie, Kate; Story, David; Short, Timothy G.; Chan, Matthew Tv; Coutts, Pauline; Sidhu, Jaspreet; Cheng, Allen C.; Bach, Leon A.; Ho, Kwok M.; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network.
In: BMJ Open, Vol. 9, No. 9, e030402, 06.09.2019.Research output: Contribution to journal › Article › Other › peer-review
TY - JOUR
T1 - The perioperative administration of dexamethasone and infection (PADDI) trial protocol
T2 - rationale and design of a pragmatic multicentre non-inferiority study
AU - Corcoran, Tomás B.
AU - Myles, Paul S.
AU - Forbes, Andrew B.
AU - O'Loughlin, Ed
AU - Leslie, Kate
AU - Story, David
AU - Short, Timothy G.
AU - Chan, Matthew Tv
AU - Coutts, Pauline
AU - Sidhu, Jaspreet
AU - Cheng, Allen C.
AU - Bach, Leon A.
AU - Ho, Kwok M.
AU - Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network
PY - 2019/9/6
Y1 - 2019/9/6
N2 - INTRODUCTION: The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications. METHODS/ANALYSIS: This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria. ETHICS/DISSEMINATION: The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020. TRIAL REGISTRATION NUMBER: ACTRN12614001226695.
AB - INTRODUCTION: The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications. METHODS/ANALYSIS: This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria. ETHICS/DISSEMINATION: The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020. TRIAL REGISTRATION NUMBER: ACTRN12614001226695.
KW - Dexamethasone
KW - Diabetes
KW - glucocorticoid
KW - Postoperative Nausea and Vomiting
KW - Surgical Wound Infection
UR - http://www.scopus.com/inward/record.url?scp=85071896727&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-030402
DO - 10.1136/bmjopen-2019-030402
M3 - Article
VL - 9
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 9
M1 - e030402
ER -