Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Drug: Control-saline; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 8 mg; Drug: Dexamethasone 8 mg; Drug: Control saline

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University HealthSystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients presenting for elective gynecologic surgery

Exclusion Criteria:

• Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to dexamethasone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control, saline 0-4 hours; 2 cc of saline	Drug: Control-saline; Patients are randomized to receive saline 2 cc
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; Drug: Dexamethasone 4 mg; Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Active Comparator: Dexamethasone 8 mg, 0-4 hours; Dexamethasone 8 mg administered intraoperatively	Drug: Dexamethasone 8 mg; Patients randomized to receive dexamethasone 8mg; Drug: Dexamethasone 8 mg; Patients are randomized to receive 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
Active Comparator: Dexamethasone 4 mg, 8-24 hours; Dexamethasone 4 mg administered intraoperatively	Drug: Dexamethasone 4 mg; Patients randomized to receive dexamethasone 4mg and 1 cc saline; Drug: Dexamethasone 4 mg; Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Active Comparator: Dexamethasone 8 mg, 8-24 hours; Dexamethasone 8 mg administered intraoperatively	Drug: Dexamethasone 8 mg; Patients randomized to receive dexamethasone 8mg; Drug: Dexamethasone 8 mg; Patients are randomized to receive dexamethasone 8 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Blood Glucose Concentrations	Serum blood glucose concentrations	Patient were followed for the duration of hospitalization, for an average of 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	VAS pain scoes at rest 0=no pain, 100=worst pain imaginable	Patients were followed for the duration of hospitalization, for an average of 6 days

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: gynecologic surgery; dexamethasone; hyperglycemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: EH08-413