Thinking of joining a study?

Register your interest

NCT06395064 | Not yet recruiting | Gynecologic Neoplasm


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

Preeyaporn Jirakittidul

Information provided by (Responsible Party):

Preeyaporn Jirakittidul

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.

Condition or disease

Gynecologic Neoplasm

Healthy Women

Intervention/treatment

Dimenhydrinate

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 160 participants
Masking : Single
Primary Purpose : Treatment
Official Title : The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
Actual Study Start Date : May 1, 2024
Estimated Primary Completion Date : December 25, 2025
Estimated Study Completion Date : April 30, 2026
Arm Intervention/treatment

Active Comparator: Dimenhydrinate

Dimenhydrinate 50 mg

Drug: Dimenhydrinate

Placebo Comparator: Placebo

NSS 10 ml

Drug: Dimenhydrinate

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Loading...