Gynecologic NeoplasmNCT06395064
The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
A study testing Dimenhydrinate in people with Gynecologic Neoplasm and Healthy Women, run by Preeyaporn Jirakittidul.
Trial summary
The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Neoplasm, Healthy Women
- 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
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2026
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years female
- undergoing trans abdominal hysterectomy
Who cannot join
- undergoing emergency surgery
- pregnancy or breastfed women
- post delivery less than 6 weeks
- history of allergic reaction or precaution to use the protocol drug
- BMI less than 18 or more than 30 kg/m2
- Need ICU care after surgery
About this study
The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.
- Conditions
- Gynecologic Neoplasm, Healthy Women
- Being tested
- Dimenhydrinate
- Keywords
- post-operative nausea vomiting
- Medical subject headings
- Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimenhydrinateDrug
Dimenhydrinate 50mg intravenously
| Study group | Role | What they receive |
|---|---|---|
| Dimenhydrinate | Active comparator | Dimenhydrinate 50 mg Receives: Drug: Dimenhydrinate |
| Placebo | Placebo comparator | NSS 10 ml Receives: Drug: Dimenhydrinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence and times of nausea vomiting
Measured: at ward, 6, 12, 24 hr postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2024 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic NeoplasmStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Preeyaporn Jirakittidul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Preeyaporn Jirakittidul, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395064
- Sponsor's protocol ID
- 313/2024
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06395064
- Acronym / sponsor ID
- 313/2024
- Conditions
- Gynecologic Neoplasm, Healthy Women
- Keywords
- post-operative nausea vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Preeyaporn JirakittidulUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- 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 aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dimenhydrinate | Active comparator | Drug: DimenhydrinateDimenhydrinate 50 mg |
| Placebo | Placebo comparator | Drug: DimenhydrinateNSS 10 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years female
- undergoing trans abdominal hysterectomy
Key exclusion criteria (6 listed)
- undergoing emergency surgery
- pregnancy or breastfed women
- post delivery less than 6 weeks
- history of allergic reaction or precaution to use the protocol drug
- BMI less than 18 or more than 30 kg/m2
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 |
|---|---|---|
| DimenhydrinateDimenhydrinate 50mg intravenously | Drug | Dimenhydrinate, Placebo |
Primary outcome
occurrence and times of nausea vomiting
Time frame: at ward, 6, 12, 24 hr postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dimenhydrinate in people with Gynecologic Neoplasm and Healthy Women, run by Preeyaporn Jirakittidul.
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 2 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: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
occurrence and times of nausea vomiting (time frame: at ward, 6, 12, 24 hr postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2024.