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Completed

NCT Number: NCT00791960

Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Dimenhydrinate

Drug

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

Other names: Gravol

Placebo

Other

single dose, 10 mL normal saline, IV

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.

    Time frame: 2 hours

Secondary outcomes

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

    Time frame: 2 hours

  2. Presence or absence of retching or vomiting.

    Time frame: 2 hours

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

    Time frame: 2 hours

  4. Type and amount of any rescue antiemetic medication used.

    Time frame: 2 hours

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

    Time frame: 2 hours

  6. Technique of uterine closure (exteriorization vs. in-situ repair).

    Time frame: 30 minutes

  7. Dose of opioid used as supplemental intravenous analgesia.

    Time frame: 2 hours

  8. Number of episodes of hypotension.

    Time frame: 2 hours

  9. Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2008
Registry last updated
Mar 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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