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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01545700
First received: February 27, 2012
Last updated: January 15, 2013
Last verified: January 2013

February 27, 2012
January 15, 2013
September 2009
November 2012   (final data collection date for primary outcome measure)
Serum Blood Glucose Concentrations [ Time Frame: Patient were followed for the duration of hospitalization, for an average of 6 days ] [ Designated as safety issue: Yes ]
Serum blood glucose concentrations
Blood glucose values [ Time Frame: Change from baseline in blood glucose values at 1,2,3,4,8, and 24 hours after baseline measurements ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01545700 on ClinicalTrials.gov Archive Site
Pain Scores [ Time Frame: Patients were followed for the duration of hospitalization, for an average of 6 days ] [ Designated as safety issue: No ]
VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
  • Pain scores [ Time Frame: 1 and 2 hours after surgery ] [ Designated as safety issue: No ]
  • Nausea and vomiting scores [ Time Frame: 2 hours after admission to the postanesthesia care unit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery

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.

Patients will be randomized on the morning of surgery to one of six groups; dexamethasone 4mg groups (0-4 hour group, 8-24 hour group), dexamethasone 8 mg groups (0-4 hour group, 8-24 hour group), or a placebo group(0-4 hour group, 8-24 hour group). Randomization will be performed using the sealed envelope method (on the basis of a block-randomized computer-generated list). The drug/placebo solution will be prepared by the pharmacy into a syringe (either 2cc of dexamethasone (8mg), 1cc dexamethasone (4mg) + 1cc normal saline, or 2cc of saline (placebo)) and delivered to one of investigators. All solutions are clear and appear identical. Patients in the dexamethasone groups will receive a standard intraoperative dose of dexamethasone (either 4mg or 8 mg) intravenously at the induction of anesthesia. Patients in the placebo groups will receive 2 cc of saline at induction of anesthesia. Study syringes will be prepared by the pharmacy, and all clinicians will be blinded to group assignment.

Primary Outcome Variable Serum Glucose levels: In the 0-4 hour patients, Blood glucose concentrations will be measured at 5 time intervals: at induction of anesthesia and at 60, 120, 180, and 240 minutes after the dexamethasone is administered. In the 8-24 hour patients, blood glucose levels will be measured at induction of anesthesia and at at 8- and 24-hours after induction. All blood samples will be measured using a portable glucometer which is calibrated daily. Blood glucose will be calculated by measuring a fingerprick capillary blood sample. The blood samples will be collected while the patient is under anesthesia and recovering from surgery.

Secondary Outcome Variables

  1. Pain scores: Postoperative pain scores will be assessed using 100 mm visual analog scale (VAS) in which 0 represents no pain and 100 represents the worst pain imaginable. Pain scores will be measured at rest and with movement at 1 and 2 hours following surgery.
  2. Nausea and vomiting scores: The incidence of nausea will be quantified using a verbal rating scale (VRS- 0=no nausea, 1=mild nausea, 2=moderate nausea, 3=severe nausea). The incidence of vomiting was quantified on a 4-point scale; 0 = (none) no episodes, 1= (mild) 1 episode, 2= (moderate) 2-3 episodes, 3= (severe) more than 3 episodes. Nausea and vomiting scores will be obtained at discharge from the PACU.
  3. PACU data: Episodes of nausea and vomiting will be recorded. Requirements for pain medication and antiemetic medication will be recorded. The time needed to meet discharge criteria and achieve actual discharge will be noted.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Complications
  • Drug: Control-saline
    Patients are randomized to receive saline 2 cc
    Other Name: Control-saline
  • Drug: Dexamethasone 4 mg
    Patients randomized to receive dexamethasone 4mg and 1 cc saline
    Other Name: Dexamethasone 4 mg
  • Drug: Dexamethasone 8 mg
    Patients randomized to receive dexamethasone 8mg
    Other Name: Dexamethasone 8 mg
  • Drug: Control saline
    Patients are randomized to receive saline 2 cc
    Other Name: Control saline
  • Drug: Dexamethasone 4 mg
    Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
    Other Name: Dexamethasone 4 mg
  • Drug: Dexamethasone 8 mg
    Patients are randomized to receive dexamethasone 8 mg
    Other Name: Dexamethasone 8 mg
  • Placebo Comparator: Control, saline 0-4 hours
    2 cc of saline
    Intervention: Drug: Control-saline
  • Active Comparator: Dexamethasone 4 mg, 0-4 hours
    Dexamethasone 4 mg administered intraoperatively
    Intervention: Drug: Dexamethasone 4 mg
  • Active Comparator: Dexamethasone 8 mg, 0-4 hours
    Dexamethasone 8 mg administered intraoperatively
    Intervention: Drug: Dexamethasone 8 mg
  • Placebo Comparator: Placebo Comparator saline 8-24 hours
    placebo, 2 cc saline
    Intervention: Drug: Control saline
  • Active Comparator: Dexamethasone 4 mg, 8-24 hours
    Dexamethasone 4 mg administered intraoperatively
    Intervention: Drug: Dexamethasone 4 mg
  • Active Comparator: Dexamethasone 8 mg, 8-24 hours
    Dexamethasone 8 mg administered intraoperatively
    Intervention: Drug: Dexamethasone 8 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients presenting for elective gynecologic surgery

Exclusion Criteria:

  • Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
Female
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01545700
EH08-413
No
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
NorthShore University HealthSystem Research Institute
Not Provided
Principal Investigator: Glenn S Murphy, MD NorthShore University HealthSystem
NorthShore University HealthSystem Research Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP