Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Condition: Postoperative Complications
MeSH terms: Hyperglycemia; Postoperative Complications
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Control-saline; Dexamethasone 4 mg; Dexamethasone 8 mg; Control saline; Dexamethasone 4 mg; Dexamethasone 8 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients are randomized to receive saline 2 cc; Patients randomized to receive dexamethasone 4mg and 1 cc saline; Patients randomized to receive dexamethasone 8mg; Patients are randomized to receive saline 2 cc; Patients are randomized to receive dexamethasone 4 mg and saline 1 cc; Patients are randomized to receive dexamethasone 8 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexamethasone; hyperglycemia; gynecologic surgery