Nausea and Vomiting, Postoperative, Shivering
Conditions
Keywords
dexmedetomidine, cesarean, spinal anesthesia
Brief summary
This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.
Detailed description
This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea. Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed. After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine. Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.
Interventions
DRUGDexmedetomidine
Administration of 10 mcg intravenous dexmedetomidine
DRUGPlacebo
Administration of normal saline
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study medication provided in blinded syringe labeled with study number
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Elective cesarean delivery * ≥ 18 years of age * Singleton pregnancy * Term delivery (37 weeks or greater gestation) * Spinal or combined spinal-epidural anesthesia is planned
Exclusion criteria
* Non-elective cesarean delivery * Receiving misoprostil or carboprost * Postpartum hemorrhage greater that 1000cc * Chronic opioid use * History of chronic nausea or itching in pregnancy * Receiving medications for nausea * Inability to provide written informed consent * Receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea * Postpartum hemorrhage greater that 1000cc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shivering measured by Visual analogue score | 60 minutes | Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
| Postoperative nausea and vomiting measured by Visual analogue score | 60 minutes | Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain measured by Visual analogue score | 60 minutes | Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
| Pruritus measured by Visual analogue score | 60 minutes | Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
| Sedation measured by Visual analogue score | 60 minutes | Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
| Dry mouth measured by Visual analogue score | 60 minutes | Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible |
Countries
United States
Outcome results
None listed