Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Complications |
Drug: Control-saline Drug: Dexamethasone 4 mg Drug: Dexamethasone 8 mg Drug: Control saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery |
- 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
- 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
| Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control, saline 0-4 hours
2 cc of saline
|
Drug: Control-saline
Patients are randomized to receive saline 2 cc
Other Name: Control-saline
|
|
Active Comparator: Dexamethasone 4 mg, 0-4 hours
Dexamethasone 4 mg administered intraoperatively
|
Drug: Dexamethasone 4 mg
Patients randomized to receive dexamethasone 4mg and 1 cc saline
Other Name: Dexamethasone 4 mg
|
|
Active Comparator: Dexamethasone 8 mg, 0-4 hours
Dexamethasone 8 mg administered intraoperatively
|
Drug: Dexamethasone 8 mg
Patients randomized to receive dexamethasone 8mg
Other Name: Dexamethasone 8 mg
|
|
Placebo Comparator: Placebo Comparator saline 8-24 hours
placebo, 2 cc saline
|
Drug: Control saline
Patients are randomized to receive saline 2 cc
Other Name: Control saline
|
|
Active Comparator: Dexamethasone 4 mg, 8-24 hours
Dexamethasone 4 mg administered intraoperatively
|
Drug: Dexamethasone 4 mg
Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Other Name: Dexamethasone 4 mg
|
|
Active Comparator: Dexamethasone 8 mg, 8-24 hours
Dexamethasone 8 mg administered intraoperatively
|
Drug: Dexamethasone 8 mg
Patients are randomized to receive dexamethasone 8 mg
Other Name: Dexamethasone 8 mg
|
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
- 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.
- 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.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients presenting for elective gynecologic surgery
Exclusion Criteria:
- Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.
Contacts and Locations| United States, Illinois | |
| NorthShore University HealthSystem | |
| Evanston, Illinois, United States, 60201 | |
| Principal Investigator: | Glenn S Murphy, MD | NorthShore University HealthSystem |
More Information
No publications provided
| Responsible Party: | Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute |
| ClinicalTrials.gov Identifier: | NCT01545700 History of Changes |
| Other Study ID Numbers: | EH08-413 |
| Study First Received: | February 27, 2012 |
| Results First Received: | November 9, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by NorthShore University HealthSystem Research Institute:
|
dexamethasone hyperglycemia gynecologic surgery |
Additional relevant MeSH terms:
|
Hyperglycemia Postoperative Complications Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013