Effect of oral betahistin in reducing of nausea and vomiting after surgery

Effect of oral betahistin in reducing of nausea and vomiting after laparoscopic cholecystectomy with general anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201225049829N1

Enrollment

120

Registered

2021-01-10

Start date

2019-10-22

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nausea and vomiting. Nausea and vomiting

Interventions

Intervention 1: Intervention group: Betahistine 16 mg tablets (manufactured by Octovorco) orally, 3 hours before surgery. Intervention 2: Control group: An oral placebo (made by Sari School of Pharmac

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: The patient's desire to participate in the study and gain informed consent Candidate for elective laparoscopic cholecystectomy Age between 15 to 60 years No history of betahistine allergy No history of gastrointestinal disease and cardiovascular disease and respiratory problems

Exclusion criteria

Exclusion criteria: Patients with uncontrolled diabetes Underlying gastrointestinal disease History of nausea and vomiting and taking anti-nausea and vomiting drugs in 24 hours before surgery Middle ear disease Pregnancy Patients with BMI> 35 High blood pressure, cardiovascular disease, diarrhea with respiratory problems If the laparoscopic surgery becomes an open cholecystectomy

Design outcomes

Primary

Measure	Time frame
Severe nausea. Timepoint: At times 1, 3, 6, 12, 24, 48 after surgery. Method of measurement: NRS (numerical rating scale).;Vomiting. Timepoint: At times 1, 3, 6, 12, 24, 48 after surgery. Method of measurement: NRS (numerical rating scale).	—

Secondary

Measure	Time frame
The amount of ondansetron and narcotics consumed. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Dry mouth. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Headache. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Itching. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.	—

Measure

Time frame

The amount of ondansetron and narcotics consumed. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Dry mouth. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Headache. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.;Itching. Timepoint: At times 1, 3, 6, 12, 24 and 48 hours after surgery. Method of measurement: Questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoume Enayati

Mazandaran University of Medical Sciences

masoumeenayati@gmail.com+98 11 3304 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026