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.

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting, Postoperative; Shivering
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Precedex
PLACEBO_COMPARATOR: Placebo; Patient will receive 5 ml of normal saline, administered by slow intravenous injection	Drug: Placebo; Administration of normal saline; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shivering measured by Visual analogue score	Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes
Postoperative nausea and vomiting measured by Visual analogue score	Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measured by Visual analogue score	Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes
Pruritus measured by Visual analogue score	Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes
Sedation measured by Visual analogue score	Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes
Dry mouth measured by Visual analogue score	Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible	60 minutes

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2020
• Primary Completion (ACTUAL): March 20, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: dexmedetomidine; spinal anesthesia; cesarean
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2017P000517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No