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Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Shivering
Nausea and Vomiting, Postoperative

Treatments

Drug: Dexmedetomidine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03370562
2017P000517

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Dexmedetomidine
Active Comparator group
Description:
Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
Treatment:
Drug: Dexmedetomidine
Placebo
Placebo Comparator group
Description:
Patient will receive 5 ml of normal saline, administered by slow intravenous injection
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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