Prophylactic Dimenhydrinate for Intraoperative Nausea and... | NCT00791960

Studies
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

NCT00791960

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Last Update Posted

Mar 29, 2010Estimated

Enrollment

149Actual

Phase

Not Applicable

Conditions

Nausea
Vomiting

Interventions

Dimenhydrinate
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
08-0206-A

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Nov 13, 2008

First Submission Date that Met QC Criteria

Nov 13, 2008

First Posted Date

Nov 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2010

Last Update Posted Date

Mar 29, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dimenhydrinate	Active Comparator	Dimenhydrinate	Drug: Dimenhydrinate
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dimenhydrinate	Drug	single dose, 25mg, IV, diluted in 9.5mL normal saline.	Dimenhydrinate

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose CA Carvalho, MD	MOUNT SINAI HOSPITAL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G 1X5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34002866	Derived	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.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004155	Diphenhydramine
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

ID	Term
D009325	Nausea
D014839	Vomiting