Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

Nausea Clinical Trial

Official title:

Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791960
• Other study ID #: 08-01
• Secondary ID: 08-0206-A
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: March 25, 2010
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2010
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Dimenhydrinate
single dose, 25mg, IV, diluted in 9.5mL normal saline.

Other:
• Placebo
single dose, 10 mL normal saline, IV

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Severity of nausea, assessed by visual analog scale (1-10)		2 hours	No
Secondary	Presence or absence of retching or vomiting.		2 hours	No
Secondary	Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.		2 hours	No
Secondary	Type and amount of any rescue antiemetic medication used.		2 hours	No
Secondary	Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.		2 hours	No
Secondary	Technique of uterine closure (exteriorization vs. in-situ repair).		30 minutes	No
Secondary	Dose of opioid used as supplemental intravenous analgesia.		2 hours	No
Secondary	Number of episodes of hypotension.		2 hours	No
Secondary	Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.		3 hours	No