Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Dimenhydrinate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dimenhydrinate<br>Dimenhydrinate | Drug: Dimenhydrinate<br>* single dose, 25mg, IV, diluted in 9.5mL normal saline.<br>* Other names: Gravol;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* single dose, 10 mL normal saline, IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Dimenhydrinate, Gravol, Antiemetics