Back to resultsProphylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dimenhydrinate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring Cesarean Section, Dimenhydrinate, Gravol, Antiemetics
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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dimenhydrinate
Placebo
Arm Description
Dimenhydrinate
Placebo
Outcomes
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.
Secondary Outcome Measures
Severity of nausea, assessed by visual analog scale (1-10)
Presence or absence of retching or vomiting.
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
Type and amount of any rescue antiemetic medication used.
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
Technique of uterine closure (exteriorization vs. in-situ repair).
Dose of opioid used as supplemental intravenous analgesia.
Number of episodes of hypotension.
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
Full Information
NCT ID
NCT00791960
First Posted
November 13, 2008
Last Updated
March 25, 2010
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00791960
Brief Title
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
Official Title
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Cesarean Section, Dimenhydrinate, Gravol, Antiemetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dimenhydrinate
Arm Type
Active Comparator
Arm Description
Dimenhydrinate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Dimenhydrinate
Other Intervention Name(s)
Gravol
Intervention Description
single dose, 25mg, IV, diluted in 9.5mL normal saline.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
single dose, 10 mL normal saline, IV
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Severity of nausea, assessed by visual analog scale (1-10)
Time Frame
2 hours
Title
Presence or absence of retching or vomiting.
Time Frame
2 hours
Title
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
Time Frame
2 hours
Title
Type and amount of any rescue antiemetic medication used.
Time Frame
2 hours
Title
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
Time Frame
2 hours
Title
Technique of uterine closure (exteriorization vs. in-situ repair).
Time Frame
30 minutes
Title
Dose of opioid used as supplemental intravenous analgesia.
Time Frame
2 hours
Title
Number of episodes of hypotension.
Time Frame
2 hours
Title
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
Time Frame
3 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34002866
Citation
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.
Results Reference
derived
Learn more about this trial
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
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