Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00791960

Collaborator

(none)

149

Enrollment

Location

Arms

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting	Drug: Dimenhydrinate Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dimenhydrinate Dimenhydrinate	Drug: Dimenhydrinate single dose, 25mg, IV, diluted in 9.5mL normal saline. Other Names: Gravol
Placebo Comparator: Placebo Placebo	Other: Placebo single dose, 10 mL normal saline, IV

Arm

Intervention/Treatment

Active Comparator: Dimenhydrinate

Dimenhydrinate

Drug: Dimenhydrinate

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

Other Names:

Gravol

Placebo Comparator: Placebo

Placebo

Other: Placebo

single dose, 10 mL normal saline, IV

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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