Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Control-saline
Dexamethasone 4 mg
Dexamethasone 8 mg
Control saline
Dexamethasone 4 mg
Dexamethasone 8 mg
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring dexamethasone, hyperglycemia, gynecologic surgery
Eligibility 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.
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control, saline 0-4 hours
Dexamethasone 4 mg, 0-4 hours
Dexamethasone 8 mg, 0-4 hours
Placebo Comparator saline 8-24 hours
Dexamethasone 4 mg, 8-24 hours
Dexamethasone 8 mg, 8-24 hours
Arm Description
2 cc of saline
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 8 mg administered intraoperatively
placebo, 2 cc saline
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 8 mg administered intraoperatively
Outcomes
Primary Outcome Measures
Serum Blood Glucose Concentrations
Serum blood glucose concentrations
Secondary Outcome Measures
Pain Scores
VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Full Information
NCT ID
NCT01545700
First Posted
February 27, 2012
Last Updated
September 12, 2019
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT01545700
Brief Title
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Official Title
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
dexamethasone, hyperglycemia, gynecologic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control, saline 0-4 hours
Arm Type
Placebo Comparator
Arm Description
2 cc of saline
Arm Title
Dexamethasone 4 mg, 0-4 hours
Arm Type
Active Comparator
Arm Description
Dexamethasone 4 mg administered intraoperatively
Arm Title
Dexamethasone 8 mg, 0-4 hours
Arm Type
Active Comparator
Arm Description
Dexamethasone 8 mg administered intraoperatively
Arm Title
Placebo Comparator saline 8-24 hours
Arm Type
Placebo Comparator
Arm Description
placebo, 2 cc saline
Arm Title
Dexamethasone 4 mg, 8-24 hours
Arm Type
Active Comparator
Arm Description
Dexamethasone 4 mg administered intraoperatively
Arm Title
Dexamethasone 8 mg, 8-24 hours
Arm Type
Active Comparator
Arm Description
Dexamethasone 8 mg administered intraoperatively
Intervention Type
Drug
Intervention Name(s)
Control-saline
Intervention Description
Patients are randomized to receive saline 2 cc
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg
Intervention Description
Patients randomized to receive dexamethasone 4mg and 1 cc saline
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8 mg
Intervention Description
Patients randomized to receive dexamethasone 8mg
Intervention Type
Drug
Intervention Name(s)
Control saline
Intervention Description
Patients are randomized to receive saline 2 cc
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 mg
Intervention Description
Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8 mg
Intervention Description
Patients are randomized to receive dexamethasone 8 mg
Primary Outcome Measure Information:
Title
Serum Blood Glucose Concentrations
Description
Serum blood glucose concentrations
Time Frame
Patient were followed for the duration of hospitalization, for an average of 6 days
Secondary Outcome Measure Information:
Title
Pain Scores
Description
VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Time Frame
Patients were followed for the duration of hospitalization, for an average of 6 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn S Murphy, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
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