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Phase 4 N=200 Randomized Quadruple-blind Treatment

Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery

Postoperative Complications

Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Serum Blood Glucose Concentrations — 101; 137; 140; 141 mg/dl

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Control-saline (Drug); Dexamethasone 4 mg (Drug); Dexamethasone 8 mg (Drug); Control saline (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Endeavor Health
Primary completion
Nov 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Serum Blood Glucose Concentrations
101; 137; 140; 141; 139; 107
SECONDARY
Pain Scores
50; 47; 45; 50; 45; 44.5

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.

Eligibility Criteria

Inclusion Criteria

  • Patients presenting for elective gynecologic surgery

Exclusion Criteria

  • Age 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01545700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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