Clinical trial

The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial

Name
313/2024
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2025-12-25
Trial end
2026-04-30
Status
Not yet recruiting
Treatment
Dimenhydrinate
Dimenhydrinate 50mg intravenously
Arms:
Dimenhydrinate, Placebo
Size
160
Primary endpoint
occurrence and times of nausea vomiting
at ward, 6, 12, 24 hr postoperation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-05-01

1 organization

1 product

2 indications

Indication
Healthy Women