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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gynecologic Neoplasm Healthy Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dimenhydrinate

Dimenhydrinate 50 mg

Group Type ACTIVE_COMPARATOR

Dimenhydrinate

Intervention Type DRUG

Dimenhydrinate 50mg intravenously

Placebo

NSS 10 ml

Group Type PLACEBO_COMPARATOR

Dimenhydrinate

Intervention Type DRUG

Dimenhydrinate 50mg intravenously

Interventions

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Dimenhydrinate

Dimenhydrinate 50mg intravenously

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes