Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Status: | Completed |
---|---|
Conditions: | Hospital, Diabetes |
Therapuetic Areas: | Endocrinology, Other |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | September 2009 |
End Date: | September 2012 |
Contact: | Glenn S Murphy, MD |
Email: | dgmurphy2@yahoo.com |
Phone: | 847-570-2760 |
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 three groups; a
dexamethasone 4mg group, a dexamethasone 8 mg group, or a placebo 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 group 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 first 100 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 second 100
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.
Inclusion Criteria:
- Patients presenting for elective gynecologic surgery
Exclusion Criteria:
- Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to
dexamethasone.
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