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NCT06395064 Clinical Trial

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

Healthy Women Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06395064
Other study ID # 313/2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date April 30, 2026

Study information
Verified date April 2024
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dimenhydrinate
Dimenhydrinate 50mg intravenously

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Preeyaporn Jirakittidul

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence and times of nausea vomiting at ward, 6, 12, 24 hr postoperation
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