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Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT00791960
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Nausea Vomiting Drug: Dimenhydrinate Other: Placebo

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial
Study Start Date : November 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Dimenhydrinate
Dimenhydrinate
Drug: Dimenhydrinate
single dose, 25mg, IV, diluted in 9.5mL normal saline.
Other Name: Gravol
Placebo Comparator: Placebo
Placebo
Other: Placebo
single dose, 10 mL normal saline, IV


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791960


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
More Information

Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00791960     History of Changes
Other Study ID Numbers: 08-01
08-0206-A
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean Section
Dimenhydrinate
Gravol
Antiemetics

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action