Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

NCT ID: NCT00791960

Last Updated: 2010-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-09-30

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dimenhydrinate

Dimenhydrinate

Group Type: ACTIVE_COMPARATOR

Dimenhydrinate

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

single dose, 10 mL normal saline, IV

Interventions

Dimenhydrinate

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

Intervention Type: DRUG

Placebo

single dose, 10 mL normal saline, IV

Intervention Type: OTHER

Other Intervention Names

Gravol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mount Sinai Hospital

Principal Investigators

Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34002866 (View on PubMed)

Other Identifiers

08-0206-A

Identifier Type: -

Identifier Source: secondary_id

08-01

Identifier Type: -

Identifier Source: org_study_id