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Completed

NCT Number: NCT03370562

Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Administration of 10 mcg intravenous dexmedetomidine

Other names: Precedex

Placebo

Drug

Administration of normal saline

Other names: Saline

Primary outcomes

  1. Shivering measured by Visual analogue score

    Time frame: 60 minutes

    Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

  2. Postoperative nausea and vomiting measured by Visual analogue score

    Time frame: 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 outcomes

  1. Pain measured by Visual analogue score

    Time frame: 60 minutes

    Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

  2. Pruritus measured by Visual analogue score

    Time frame: 60 minutes

    Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

  3. Sedation measured by Visual analogue score

    Time frame: 60 minutes

    Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible

  4. Dry mouth measured by Visual analogue score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2017
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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