NauseaNCT00791960
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
A study testing Dimenhydrinate in people with Nausea and Vomiting, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Dimenhydrinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dimenhydrinate, Placebo
- Keywords
- Cesarean Section, Dimenhydrinate, Gravol, Antiemetics
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimenhydrinateDrug
Also called Gravol
single dose, 25mg, IV, diluted in 9.5mL normal saline.
PlaceboOther
single dose, 10 mL normal saline, IV
| Study group | Role | What they receive |
|---|---|---|
| Dimenhydrinate | Active comparator | Dimenhydrinate Receives: Drug: Dimenhydrinate |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (9)
Severity of nausea, assessed by visual analog scale (1-10)
Measured: 2 hours
Presence or absence of retching or vomiting.
Measured: 2 hours
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
Measured: 2 hours
Type and amount of any rescue antiemetic medication used.
Measured: 2 hours
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
Measured: 2 hours
Technique of uterine closure (exteriorization vs. in-situ repair).
Measured: 30 minutes
Dose of opioid used as supplemental intravenous analgesia.
Measured: 2 hours
Number of episodes of hypotension.
Measured: 2 hours
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791960
- Sponsor's protocol ID
- 08-01
- Other IDs
- 08-0206-A
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2008
- Last updated
- 29 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34002866
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting: A Randomized, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00791960
- Acronym / sponsor ID
- 08-01
- Keywords
- Cesarean Section, Dimenhydrinate, Gravol, Antiemetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dimenhydrinate | Active comparator | Drug: DimenhydrinateDimenhydrinate |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DimenhydrinateAlso: Gravolsingle dose, 25mg, IV, diluted in 9.5mL normal saline. | Drug | Dimenhydrinate |
| Placebosingle dose, 10 mL normal saline, IV | Other | Placebo |
Primary outcome
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
9 secondary outcomes
Severity of nausea, assessed by visual analog scale (1-10)
Time frame: 2 hours
Presence or absence of retching or vomiting.
Time frame: 2 hours
Patient sedation as measured by the Ramsay sedation scale. This will be recorded preoperatively, intraoperatively and postoperatively.
Time frame: 2 hours
Type and amount of any rescue antiemetic medication used.
Time frame: 2 hours
Newborn Apgar scores at 1 and 5 minutes, as well as any NICU admission.
Time frame: 2 hours
Technique of uterine closure (exteriorization vs. in-situ repair).
Time frame: 30 minutes
Dose of opioid used as supplemental intravenous analgesia.
Time frame: 2 hours
Number of episodes of hypotension.
Time frame: 2 hours
Occurence of side effects: tachycardia, dizziness, restlessness, dry mouth, and desaturation.
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2010.
- Derived from this study: PubMed 34002866Griffiths 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dimenhydrinate in people with Nausea and Vomiting, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00791960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2010.