NCT03370562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

November 27, 2017

Last Update Submit

September 25, 2021

Conditions

ShiveringNausea and Vomiting, Postoperative

Keywords

dexmedetomidinecesareanspinal anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Pain measured by Visual analogue score

    60 minutes

  • Pruritus measured by Visual analogue score

    60 minutes

  • Sedation measured by Visual analogue score

    60 minutes

  • Dry mouth measured by Visual analogue score

    60 minutes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DexmedetomidineDRUG

Administration of 10 mcg intravenous dexmedetomidine

Also known as: Precedex
Dexmedetomidine
PlaceboDRUG

Administration of normal saline

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females will be enrolled
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective cesarean delivery
  • ≥ 18 years of age
  • Singleton pregnancy
  • Term delivery (37 weeks or greater gestation)
  • Spinal or combined spinal-epidural anesthesia is planned

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Philip E Hess, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study medication provided in blinded syringe labeled with study number
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 12, 2017

Study Start

February 18, 2020

Primary Completion

March 20, 2020

Study Completion

December 31, 2020

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)