Clinical trial NCT00791960: Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
Official title: Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Cesarean Section
Dimenhydrinate
Gravol
Antiemetics
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 2 hours
Secondary outcomes:
measure: Severity of nausea, assessed by visual analog scale (1-10)
timeFrame: 2 hours
measure: Presence or absence of retching or vomiting.
timeFrame: 2 hours
measure: Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
timeFrame: 2 hours
measure: Type and amount of any rescue antiemetic medication used.
timeFrame: 2 hours
measure: Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
timeFrame: 2 hours
measure: Technique of uterine closure (exteriorization vs. in-situ repair).
timeFrame: 30 minutes
measure: Dose of opioid used as supplemental intravenous analgesia.
timeFrame: 2 hours
measure: Number of episodes of hypotension.
timeFrame: 2 hours
measure: Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
timeFrame: 3 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.