Dose Finding Study, Shivering
Conditions
Keywords
Shivering, Cesarean Delivery, Dexmedetomidine, Dosing
Brief summary
The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.
Detailed description
Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade 3 or 4 shivering at the time of delivery then they will be enrolled in the study. Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine. Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales. * Grade 0: no shivering; * Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group; * Grade 3: visible muscle activity in more than one muscle group; * Grade 4: gross muscle activity involving the whole body
Interventions
DRUGDexmedetomidine
Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women presenting for planned cesarean delivery. * American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities. * Singleton gestation in the 3rd trimester (28-42 weeks gestation). * Spinal anesthesia technique Women presenting for planned cesarean delivery. * American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities. * Singleton gestation in the 3rd trimester (28-42 weeks gestation). * Spinal anesthesia technique.
Exclusion criteria
* Any contraindication to spinal anesthesia technique. * Allergy or intolerance to dexmedetomidine or clonidine. * Oral temperature \< 36° Celsius prior to procedure. * Unable to give personal consent. * PPROM or concern for infection (e.g., chorioamnionitis). * Conversion to General Anesthesia prior to randomization. * Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan | 5 minutes after administration of the drug | Cessation of shivering |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Heart Rate | During intraoperative course | Determination of the effect of varying doses of dexmedetomidine on maternal heart rate. |
| Doses of dexmedetomidine | During intraoperative course | Determination of the effect of varying doses of dexmedetomidine on maternal sedation. |
Countries
United States
Contacts
Primary ContactHans P Sviggum, MD
Outcome results
None listed