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
  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

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545700

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
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 July 22, 2014