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

NCT06395064 — Not applicable, Unknown, 160 participants, Preeyaporn Jirakittidul

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RegistryNCT06395064
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment160 (Estimated)
SponsorPreeyaporn Jirakittidul (Other)
ConditionsGynecologic Neoplasm, Healthy Women
InterventionsDimenhydrinate (Drug)
Datesstart 2024-05-01 (estimated), primary completion 2025-12-25 (estimated), completion 2026-04-30 (estimated), first posted 2024-05-01, last updated 2024-05-01

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
DimenhydrinateActive comparatorDrug: DimenhydrinateDimenhydrinate 50 mg
PlaceboPlacebo comparatorDrug: DimenhydrinateNSS 10 ml
  • Dimenhydrinate (Drug): Dimenhydrinate 50mg intravenously

+Outcome measures

Primary outcomes

  • occurrence and times of nausea vomiting [at ward, 6, 12, 24 hr postoperation]

+Eligibility

Sex: Female, ages: 18 Years to 65 Years, 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