Postoperative Complications
Conditions
Keywords
dexamethasone, hyperglycemia, gynecologic surgery
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 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.
Interventions
DRUGControl-saline
Patients are randomized to receive saline 2 cc
Patients randomized to receive dexamethasone 4mg and 1 cc saline
Patients randomized to receive dexamethasone 8mg
DRUGControl saline
Patients are randomized to receive saline 2 cc
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Blood Glucose Concentrations | Patient were followed for the duration of hospitalization, for an average of 6 days | Serum blood glucose concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | Patients were followed for the duration of hospitalization, for an average of 6 days | VAS pain scoes at rest 0=no pain, 100=worst pain imaginable |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
A total of 200 patients were enrolled in this clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| Control, Saline 0-4 Hours 2 cc of saline
Control-saline : Patients are randomized to receive saline 2 cc | 34 |
| Dexamethasone 4 mg, 0-4 Hours Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline | 33 |
| Dexamethasone 8 mg, 0-4 Hours Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg | 33 |
| Placebo Comparator Saline 8-24 Hours placebo, 2 cc saline
Control saline : Patients are randomized to receive saline 2 cc | 34 |
| 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 | 33 |
| Dexamethasone 8 mg, 8-24 Hours Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg | 33 |
| Total | 200 |
Baseline characteristics
| Characteristic | Dexamethasone 4 mg, 0-4 Hours | Dexamethasone 8 mg, 0-4 Hours | Placebo Comparator Saline 8-24 Hours | Control, Saline 0-4 Hours | Dexamethasone 4 mg, 8-24 Hours | Dexamethasone 8 mg, 8-24 Hours | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 9 Participants | 5 Participants | 5 Participants | 5 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 30 Participants | 25 Participants | 29 Participants | 28 Participants | 28 Participants | 169 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 9 | 53 years STANDARD_DEVIATION 11 | 57 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 10 | 53 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 33 participants | 33 participants | 34 participants | 34 participants | 33 participants | 33 participants | 200 participants |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 34 Participants | 34 Participants | 33 Participants | 33 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 128 |
| serious Total, serious adverse events | 0 / 67 | 0 / 128 |
Outcome results
Primary
Serum Blood Glucose Concentrations
Serum blood glucose concentrations
Time frame: Patient were followed for the duration of hospitalization, for an average of 6 days
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo 0-4 Hours | Serum Blood Glucose Concentrations | 101 mg/dl | Standard Deviation 15 |
| Dexamethasone 4 mg 0-4 Hours | Serum Blood Glucose Concentrations | 137 mg/dl | Standard Deviation 29 |
| Dexamethasone 8 mg 0-4 Hours | Serum Blood Glucose Concentrations | 140 mg/dl | Standard Deviation 28 |
| Placebo 8-24 Hours | Serum Blood Glucose Concentrations | 141 mg/dl | Standard Deviation 34 |
| Dexamethasone 4 mg 8-24 Hours | Serum Blood Glucose Concentrations | 139 mg/dl | Standard Deviation 34 |
| Dexamethasone 8 mg 8-24 Hours | Serum Blood Glucose Concentrations | 107 mg/dl | Standard Deviation 21 |
| Dexamethasone 4 mg 0-4 Hours-1 Hour | Serum Blood Glucose Concentrations | 141 mg/dl | Standard Deviation 23 |
| Dexamethasone 4 mg 0-4 Hours-2 Hours | Serum Blood Glucose Concentrations | 159 mg/dl | Standard Deviation 33 |
| Dexamethasone 4 mg 0-4 Hours-3 Hours | Serum Blood Glucose Concentrations | 159 mg/dl | Standard Deviation 30 |
| Dexamethasone 4 mg 0-4 Hours-4 Hours | Serum Blood Glucose Concentrations | 159 mg/dl | Standard Deviation 25 |
| Dexamethasone 8 mg 0-4 Hours-baseline | Serum Blood Glucose Concentrations | 108 mg/dl | Standard Deviation 23 |
| Dexamethasone 8 mg 0-4 Hours-1 Hour | Serum Blood Glucose Concentrations | 138 mg/dl | Standard Deviation 27 |
| Dexamethasone 8 mg 0-4 Hours-2 Hours | Serum Blood Glucose Concentrations | 151 mg/dl | Standard Deviation 23 |
| Dexamethasone 8 mg 0-4 Hours-3 Hours | Serum Blood Glucose Concentrations | 146 mg/dl | Standard Deviation 22 |
| Dexamethasone 8 mg 0-4 Hours-4 Hours | Serum Blood Glucose Concentrations | 149 mg/dl | Standard Deviation 25 |
| Placebo 8-24 Hours Baseline | Serum Blood Glucose Concentrations | 101 mg/dl | Standard Deviation 19 |
| Placebo 8-24 Hours-8 Hours | Serum Blood Glucose Concentrations | 150 mg/dl | Standard Deviation 36 |
| Placebo 8-24 Hours-24 Hours | Serum Blood Glucose Concentrations | 121 mg/dl | Standard Deviation 26 |
| Dexamethasone 4 mg 8-24 Hours-baseline | Serum Blood Glucose Concentrations | 98 mg/dl | Standard Deviation 16 |
| Dexamethasone 4 mg 8-24 Hours-8 Hours | Serum Blood Glucose Concentrations | 149 mg/dl | Standard Deviation 28 |
| Dexamethasone 4 mg 8-24 Hours-24 Hours | Serum Blood Glucose Concentrations | 119 mg/dl | Standard Deviation 16 |
| Dexamethasone 8 mg 8-24 Hours-baseline | Serum Blood Glucose Concentrations | 100 mg/dl | Standard Deviation 19 |
| Dexamethasone 8 mg 8-24 Hours-8 Hours | Serum Blood Glucose Concentrations | 151 mg/dl | Standard Deviation 36 |
| Dexamethasone 8 mg 8-24 Hours-24 Hours | Serum Blood Glucose Concentrations | 124 mg/dl | Standard Deviation 27 |
Secondary
Pain Scores
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo 0-4 Hours | Pain Scores | 50 0-100 VAS scale scores on a scale | Standard Deviation 21 |
| Dexamethasone 4 mg 0-4 Hours | Pain Scores | 47 0-100 VAS scale scores on a scale | Standard Deviation 26 |
| Dexamethasone 8 mg 0-4 Hours | Pain Scores | 45 0-100 VAS scale scores on a scale | Standard Deviation 24 |
| Placebo 8-24 Hours | Pain Scores | 50 0-100 VAS scale scores on a scale | Standard Deviation 21 |
| Dexamethasone 4 mg 8-24 Hours | Pain Scores | 45 0-100 VAS scale scores on a scale | Standard Deviation 17 |
| Dexamethasone 8 mg 8-24 Hours | Pain Scores | 44.5 0-100 VAS scale scores on a scale | Standard Deviation 23 |