Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
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.
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Postoperative Complications
Intervention
Control-saline, Dexamethasone 4 mg, Dexamethasone 8 mg, Control saline, Dexamethasone 4 mg, Dexamethasone 8 mg
Location
NorthShore University HealthSystem
Evanston
Illinois
United States
60201
Status
Completed
Source
NorthShore University HealthSystem Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01545700
- Information obtained from ClinicalTrials.gov on February 13, 2013
Medical and Biotech [MESH] Definitions
Dexamethasone
An anti-inflammatory 9-fluoro-glucocorticoid.
Dexamethasone Isonicotinate
An anti-inflammatory, anti-allergic glucocorticoid that can be administered orally, by inhalation, locally, and parenterally. It may cause water and salt retention.
Glucocorticoid-induced Tnfr-related Protein
A member of the TNF receptor family that was initially identified as a DEXAMETHASONE-induced protein from a T-CELL line. It may play a role in regulating APOPTOSIS and modulating immune response by T-lymphocytes. Signaling by the activated receptor occurs through its association with TNF RECEPTOR-ASSOCIATED FACTORS.
Haloarcula
A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.
Halomonadaceae
A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.
Clinical Trials
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients
This is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before...
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of sta...
Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain s...
Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basa...
Dexamethasone for Paediatric Adeno-Tonsillectomy - A Dose-Finding Study
Adeno-tonsillectomy is a commonly performed surgical procedure in children.Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage.Non-steroidal anti-inflammatory dru...
PubMed Articles
Novel agents are considered standard components of induction therapy for newly diagnosed patients with multiple myeloma. We retrospectively compared the results of three consecutive phase 2 clinical t...
Aim: To protect hearing during cochlear implantation with systemic administration of dexamethasone. Methods: Seventeen normal-hearing guinea pigs were randomly allocated to receive an intravenous inje...
We aimed to investigate the possible role of creatine (CR) supplementation in counteracting dexamethasone-induced muscle wasting and insulin resistance in rats. Also, we examined whether CR intake wou...
Dexamethasone eye drops containing γ-cyclodextrin-based nanogels.
Sustained release aqueous eye drops of dexamethasone, based on cyclodextrin (CD) nanogels, were designed and tested in vivo. γCD units were cross-linked in the form of nanogels by means of an emulsif...
Objective: To investigate how long-term treatment with dexamethasone affects energy expenditure and adiposity in mice and whether this is influenced by feeding on a high fat diet (HFD). Design and Met...
