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Trial Title:
The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
NCT ID:
NCT06395064
Condition:
Gynecologic Neoplasm
Healthy Women
Conditions: Official terms:
Genital Neoplasms, Female
Nausea
Vomiting
Postoperative Nausea and Vomiting
Dimenhydrinate
Conditions: Keywords:
post-operative nausea vomiting
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Dimenhydrinate
Description:
Dimenhydrinate 50mg intravenously
Arm group label:
Dimenhydrinate
Arm group label:
Placebo
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
May 1, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Preeyaporn Jirakittidul
Agency class:
Other
Source:
Mahidol University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395064
