Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
- Conditions
- ShiveringNausea and Vomiting, Postoperative
- Interventions
- Drug: Placebo
- Registration Number
- NCT03370562
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Elective cesarean delivery
- ≥ 18 years of age
- Singleton pregnancy
- Term delivery (37 weeks or greater gestation)
- Spinal or combined spinal-epidural anesthesia is planned
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patient will receive 5 ml of normal saline, administered by slow intravenous injection Dexmedetomidine Dexmedetomidine Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States