Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

Last updated: March 25, 2010
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Overall Status: Completed

Phase

N/A

Condition

Lactose Intolerance

Colic

Vomiting

Treatment

N/A

Clinical Study ID

NCT00791960
08-01
08-0206-A
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 149
Study Start date:
November 01, 2008
Estimated Completion Date:
September 30, 2009

Study Description

Nausea and vomiting remain one of the most common complications of Cesarean delivery. The results of this study will show whether or not we can improve our present anesthesia regimen, and improve the satisfaction of patients undergoing Cesarean deliveries, by reducing the incidence of nausea and vomiting. Our current practice is not to use any medication for preventing nausea and vomiting unless required. However, nausea and vomiting come quite fast and unexpectedly during the operation, and most of the time the medication we give does not work fast enough. We are planning to study the anti-nausea medication dimenhydrinate (commonly known as Gravol), which has been safely and widely used during pregnancy, labour and Cesarean deliveries, hoping that its use will decrease the incidence of this unpleasant occurrence.

Connect with a study center

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

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