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Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

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ClinicalTrials.gov Identifier: NCT03370562
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Phillip Hess, 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.

Condition or disease Intervention/treatment Phase
Shivering Nausea and Vomiting, Postoperative Drug: Dexmedetomidine Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study medication provided in blinded syringe labeled with study number
Primary Purpose: Treatment
Official Title: Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine
Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
Drug: Dexmedetomidine
Administration of 10 mcg intravenous dexmedetomidine
Other Name: Precedex

Placebo Comparator: Placebo
Patient will receive 5 ml of normal saline, administered by slow intravenous injection
Drug: Placebo
Administration of normal saline
Other Name: Saline




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females will be enrolled
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370562


Contacts
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Contact: Philip E Hess, MD 617-667-3353 phess@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Philip E Hess, MD Beth Israel Deaconess Medical Center

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Responsible Party: Phillip Hess, Staff Anesthesiologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03370562     History of Changes
Other Study ID Numbers: 2017P000517
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Phillip Hess, Beth Israel Deaconess Medical Center:
dexmedetomidine
cesarean
spinal anesthesia

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action