Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
1 other identifier
interventional
200
1 country
1
Brief Summary
The question of a possible hyperglycemic effect from single-dose dexamethasone is an important issue for clinicians managing patients in the intraoperative and postoperative periods. Recent evidence suggests that even moderate elevations in blood glucose levels may be associated with adverse events. The aim of this clinical investigation is to determine whether standard clinical doses of dexamethasone produce hyperglycemia in the perioperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
January 15, 2013
CompletedSeptember 30, 2019
September 1, 2019
3.2 years
February 27, 2012
November 9, 2012
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Blood Glucose Concentrations
Serum blood glucose concentrations
Patient were followed for the duration of hospitalization, for an average of 6 days
Secondary Outcomes (1)
Pain Scores
Patients were followed for the duration of hospitalization, for an average of 6 days
Study Arms (6)
Control, saline 0-4 hours
PLACEBO COMPARATOR2 cc of saline
Dexamethasone 4 mg, 0-4 hours
ACTIVE COMPARATORDexamethasone 4 mg administered intraoperatively
Dexamethasone 8 mg, 0-4 hours
ACTIVE COMPARATORDexamethasone 8 mg administered intraoperatively
Placebo Comparator saline 8-24 hours
PLACEBO COMPARATORplacebo, 2 cc saline
Dexamethasone 4 mg, 8-24 hours
ACTIVE COMPARATORDexamethasone 4 mg administered intraoperatively
Dexamethasone 8 mg, 8-24 hours
ACTIVE COMPARATORDexamethasone 8 mg administered intraoperatively
Interventions
Patients randomized to receive dexamethasone 4mg and 1 cc saline
Patients are randomized to receive saline 2 cc
Eligibility Criteria
You may qualify if:
- Patients presenting for elective gynecologic surgery
You may not qualify if:
- Age \< 18 or \> 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Glenn S. Murphy, MD
- Organization
- NorthShore University HealthSystem
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn S Murphy, MD
Endeavor Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Cardiac Anesthesia and Clinical Research
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 7, 2012
Study Start
September 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
September 30, 2019
Results First Posted
January 15, 2013
Record last verified: 2019-09