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

NCT06395064 | Not Yet Recruiting DMC

• 1 other identifier: 313/2024
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gynecologic Neoplasm; Healthy Women

Keywords

post-operative nausea vomiting

Outcome Measures

Primary Outcomes (1)

• occurrence and times of nausea vomiting

  at ward, 6, 12, 24 hr postoperation

Study Arms (2)

Dimenhydrinate

ACTIVE COMPARATOR

Dimenhydrinate 50 mg

Drug: Dimenhydrinate

Placebo

PLACEBO COMPARATOR

NSS 10 ml

Drug: Dimenhydrinate

Interventions

Dimenhydrinate DRUG

Dimenhydrinate 50mg intravenously

Dimenhydrinate; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years female
• undergoing trans abdominal hysterectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Preeyaporn Jirakittidul: lead

MeSH Terms

Conditions

Genital Neoplasms, Female

Interventions

Dimenhydrinate

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diphenhydramine; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist Prof Dr. Preeyaporn Jirakittidul

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: December 25, 2025
• Study Completion: April 30, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share