Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, saline 0-4 hours | Placebo Comparator | 2 cc of saline |
|
| Dexamethasone 4 mg, 0-4 hours | Active Comparator | Dexamethasone 4 mg administered intraoperatively |
|
| Dexamethasone 8 mg, 0-4 hours | Active Comparator | Dexamethasone 8 mg administered intraoperatively |
|
| Placebo Comparator saline 8-24 hours | Placebo Comparator | placebo, 2 cc saline |
|
| Dexamethasone 4 mg, 8-24 hours | Active Comparator | Dexamethasone 4 mg administered intraoperatively |
|
| Dexamethasone 8 mg, 8-24 hours | Active Comparator | Dexamethasone 8 mg administered intraoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control-saline | Drug | Patients are randomized to receive saline 2 cc |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn S Murphy, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
A total of 200 patients were enrolled in this clinical trial.
This study was conducted at NorthShore University HealthSystem (a single tertiary medical center affiliated with the University of Chicago Pritzker School of Medicine) and was registered with ClinicalTrials.gov (NCT #01545700). Participants were recruited by reviewing operating room schedules and contact by telephone on the day before surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control, Saline 0-4 Hours | 2 cc of saline Control-saline : Patients are randomized to receive saline 2 cc |
| FG001 | Dexamethasone 4 mg, 0-4 Hours | Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline |
| FG002 | Dexamethasone 8 mg, 0-4 Hours | Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg |
| FG003 | Placebo Comparator Saline 8-24 Hours | placebo, 2 cc saline Control saline : Patients are randomized to receive saline 2 cc |
| FG004 | Dexamethasone 4 mg, 8-24 Hours | Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc |
| FG005 | Dexamethasone 8 mg, 8-24 Hours | Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control, Saline 0-4 Hours | 2 cc of saline Control-saline : Patients are randomized to receive saline 2 cc |
| BG001 | Dexamethasone 4 mg, 0-4 Hours | Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pain Scores | VAS pain scoes at rest 0=no pain, 100=worst pain imaginable | Posted | Mean | Standard Deviation | 0-100 VAS scale scores on a scale | Patients were followed for the duration of hospitalization, for an average of 6 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control-saline Group |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn S. Murphy, MD | NorthShore University HealthSystem | 847-570-2760 | dgmurphy2@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexamethasone 4 mg |
| Drug |
Patients randomized to receive dexamethasone 4mg and 1 cc saline |
|
| Dexamethasone 8 mg | Drug | Patients randomized to receive dexamethasone 8mg |
|
| Control saline | Drug | Patients are randomized to receive saline 2 cc |
|
| Dexamethasone 4 mg | Drug | Patients are randomized to receive dexamethasone 4 mg and saline 1 cc |
|
| Dexamethasone 8 mg | Drug | Patients are randomized to receive dexamethasone 8 mg |
|
| BG002 | Dexamethasone 8 mg, 0-4 Hours | Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg |
| BG003 | Placebo Comparator Saline 8-24 Hours | placebo, 2 cc saline Control saline : Patients are randomized to receive saline 2 cc |
| BG004 | Dexamethasone 4 mg, 8-24 Hours | Dexamethasone 4 mg administered intraoperatively Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc |
| BG005 | Dexamethasone 8 mg, 8-24 Hours | Dexamethasone 8 mg administered intraoperatively Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG004 | Dexamethasone 4 mg 8-24 Hours |
| OG005 | Dexamethasone 8 mg 8-24 Hours |
|
|
| Primary | Serum Blood Glucose Concentrations | Serum blood glucose concentrations | per protocol | Posted | Mean | Standard Deviation | mg/dl | Patient were followed for the duration of hospitalization, for an average of 6 days |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Dexamethasone Group | either 4 mg or 8 mg | 0 | 128 | 0 | 128 |
Not provided
Not provided
Not provided
| D009750 | Nutritional and Metabolic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |