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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial|
- 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 ]
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Dimenhydrinate
single dose, 25mg, IV, diluted in 9.5mL normal saline.
Other Name: Gravol
Placebo Comparator: Placebo
single dose, 10 mL normal saline, IV
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791960
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|