- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00791960
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
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
single dose, 10 mL normal saline, IV
|
ACTIVE_COMPARATOR: Dimenhydrinate
|
single dose, 25mg, IV, diluted in 9.5mL normal saline.
Other Names:
|
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.
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severity of nausea, assessed by visual analog scale (1-10)
Time Frame: 2 hours
|
2 hours
|
Presence or absence of retching or vomiting.
Time Frame: 2 hours
|
2 hours
|
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
Time Frame: 2 hours
|
2 hours
|
Type and amount of any rescue antiemetic medication used.
Time Frame: 2 hours
|
2 hours
|
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
Time Frame: 2 hours
|
2 hours
|
Technique of uterine closure (exteriorization vs. in-situ repair).
Time Frame: 30 minutes
|
30 minutes
|
Dose of opioid used as supplemental intravenous analgesia.
Time Frame: 2 hours
|
2 hours
|
Number of episodes of hypotension.
Time Frame: 2 hours
|
2 hours
|
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
Time Frame: 3 hours
|
3 hours
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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