Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

N/ACompletedNCT00791960

Samuel Lunenfeld Research Institute, Mount Sinai Hospital149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

149

Conditions

Nausea Vomiting

Interventions

DimenhydrinateDRUG

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

PlaceboOTHER

single dose, 10 mL normal saline, IV

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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

Time frame: 2 hours

Presence or absence of retching or vomiting.

Time frame: 2 hours

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

Time frame: 2 hours

Type and amount of any rescue antiemetic medication used.

Time frame: 2 hours

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

Time frame: 2 hours

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

Time frame: 30 minutes

Dose of opioid used as supplemental intravenous analgesia.

Time frame: 2 hours

Number of episodes of hypotension.

Time frame: 2 hours

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

Time frame: 3 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.