Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
NCT ID: NCT03370562
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-02-18
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine
Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
Dexmedetomidine
Administration of 10 mcg intravenous dexmedetomidine
Placebo
Patient will receive 5 ml of normal saline, administered by slow intravenous injection
Placebo
Administration of normal saline
Interventions
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Dexmedetomidine
Administration of 10 mcg intravenous dexmedetomidine
Placebo
Administration of normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years of age
* Singleton pregnancy
* Term delivery (37 weeks or greater gestation)
* Spinal or combined spinal-epidural anesthesia is planned
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Phillip Hess
Staff Anesthesiologist
Principal Investigators
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Philip E Hess, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2017P000517
Identifier Type: -
Identifier Source: org_study_id
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