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

Preeyaporn Jirakittidul

Status: Not yet enrolling

Conditions: Gynecologic Neoplasm; Healthy Women

Treatments: Drug: Dimenhydrinate

Study type: Interventional

Funder types: Other

Identifiers

NCT06395064

313/2024

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups, including a placebo group

Dimenhydrinate

Active Comparator group

Description:

Dimenhydrinate 50 mg

Treatment:

Drug: Dimenhydrinate

Placebo

Placebo Comparator group

Description:

NSS 10 ml

Treatment:

Drug: Dimenhydrinate