Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00791960
First received: November 13, 2008
Last updated: March 25, 2010
Last verified: March 2010

November 13, 2008
March 25, 2010
November 2008
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791960 on ClinicalTrials.gov Archive Site
  • Severity of nausea, assessed by visual analog scale (1-10) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Presence or absence of retching or vomiting. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Type and amount of any rescue antiemetic medication used. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Technique of uterine closure (exteriorization vs. in-situ repair). [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Dose of opioid used as supplemental intravenous analgesia. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of episodes of hypotension. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation. [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • Drug: Dimenhydrinate
    single dose, 25mg, IV, diluted in 9.5mL normal saline.
    Other Name: Gravol
  • Other: Placebo
    single dose, 10 mL normal saline, IV
  • Active Comparator: Dimenhydrinate
    Dimenhydrinate
    Intervention: Drug: Dimenhydrinate
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00791960
08-01, 08-0206-A
No
Dr. Jose C.A. Carvalho, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP