Healthy Women Clinical Trial
Official title:
The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
Verified date | April 2024 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | April 30, 2026 |
Est. primary completion date | December 25, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 years female - undergoing trans abdominal hysterectomy Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Preeyaporn Jirakittidul |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | occurrence and times of nausea vomiting | at ward, 6, 12, 24 hr postoperation |
Status | Clinical Trial | Phase | |
---|---|---|---|
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