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Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

Primary Purpose

Shivering, Nausea and Vomiting, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shivering focused on measuring dexmedetomidine, cesarean, spinal anesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection

Patient will receive 5 ml of normal saline, administered by slow intravenous injection

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
November 27, 2017
Last Updated
September 25, 2021
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03370562
Brief Title
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Official Title
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shivering, Nausea and Vomiting, Postoperative
Keywords
dexmedetomidine, cesarean, spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study medication provided in blinded syringe labeled with study number
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient will receive 5 ml of normal saline, administered by slow intravenous injection
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Administration of 10 mcg intravenous dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Administration of normal saline
Primary Outcome Measure Information:
Title
Shivering measured by Visual analogue score
Description
Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes
Title
Postoperative nausea and vomiting measured by Visual analogue score
Description
Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Pain measured by Visual analogue score
Description
Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes
Title
Pruritus measured by Visual analogue score
Description
Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes
Title
Sedation measured by Visual analogue score
Description
Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes
Title
Dry mouth measured by Visual analogue score
Description
Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Time Frame
60 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females will be enrolled
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Hess, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

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