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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; single dose, 10 mL normal saline, IV
ACTIVE_COMPARATOR: Dimenhydrinate	Drug: Dimenhydrinate; single dose, 25mg, IV, diluted in 9.5mL normal saline.; Other Names: Gravol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of nausea, assessed by visual analog scale (1-10)	2 hours
Presence or absence of retching or vomiting.	2 hours
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.	2 hours
Type and amount of any rescue antiemetic medication used.	2 hours
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.	2 hours
Technique of uterine closure (exteriorization vs. in-situ repair).	30 minutes
Dose of opioid used as supplemental intravenous analgesia.	2 hours
Number of episodes of hypotension.	2 hours
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.	3 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (ESTIMATE): November 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 29, 2010
• Last Update Submitted That Met QC Criteria: March 25, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Cesarean Section; Dimenhydrinate; Antiemetics; Gravol
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Dimenhydrinate
• Other Study ID Numbers: 08-01; 08-0206-A