Clinical trial NCT03370562: Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Official title: Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shivering
Nausea and Vomiting, Postoperative
Keywords: dexmedetomidine
cesarean
spinal anesthesia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shivering measured by Visual analogue score
timeFrame: 60 minutes
measure: Postoperative nausea and vomiting measured by Visual analogue score
timeFrame: 60 minutes
Secondary outcomes:
measure: Pain measured by Visual analogue score
timeFrame: 60 minutes
measure: Pruritus measured by Visual analogue score
timeFrame: 60 minutes
measure: Sedation measured by Visual analogue score
timeFrame: 60 minutes
measure: Dry mouth measured by Visual analogue score
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Philip E Hess, MD
role: PRINCIPAL_INVESTIGATOR
References: