NCT00791960

Brief Summary

The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery. This medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

10 months

First QC Date

November 13, 2008

Last Update Submit

March 25, 2010

Conditions

NauseaVomiting

Keywords

Cesarean SectionDimenhydrinateGravolAntiemetics

Outcome Measures

Primary Outcomes (1)

  • Incidence of pre or post-delivery nausea as reported by the patient. Nausea will be defined as a subjectively unpleasant sensation associated with urge to vomit.

    2 hours

Secondary Outcomes (9)

  • Severity of nausea, assessed by visual analog scale (1-10)

    2 hours

  • Presence or absence of retching or vomiting.

    2 hours

  • Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.

    2 hours

  • Type and amount of any rescue antiemetic medication used.

    2 hours

  • Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.

    2 hours

  • +4 more secondary outcomes

Study Arms (2)

Dimenhydrinate

ACTIVE COMPARATOR

Dimenhydrinate

Drug: Dimenhydrinate

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

DimenhydrinateDRUG

single dose, 25mg, IV, diluted in 9.5mL normal saline.

Also known as: Gravol
Dimenhydrinate
PlaceboOTHER

single dose, 10 mL normal saline, IV

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients undergoing elective Cesarean deliveries under spinal anesthesia.
  • All patients who gave written informed consent to participate in this study.
  • ASA I and II patients.
  • Full term normal pregnancy.

You may not qualify if:

  • All patients who refuse to give written informed consent.
  • All patients who claim allergy or hypersensitivity to dimenhydrinate.
  • Patients with history of vomiting within 24 hours prior to Cesarean delivery.
  • Patients with history of gastrointestinal or psychiatric diseases and morbid obesity
  • Patients receiving any of the following drugs within 24 hours before the study: opioids, antiemetics, H2 antagonists, phenothiazine and corticosteroids.
  • Patients with severe pregnancy induced hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

  • Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

    PMID: 34002866DERIVED

MeSH Terms

Conditions

NauseaVomiting

Interventions

Dimenhydrinate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphenhydramineEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTheophyllineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 17, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

CA(1)