Skip to content

Prophylactic antiemetic effects of Ondansetron and Haloperidol patients undergoing mastectomy- double-blind clinical trial

Comparison between prophylactic antiemetic effects of Ondansetron and Haloperidol patients undergoing mastectomy- double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240224061097N1
Enrollment
50
Registered
2024-03-14
Start date
2024-04-26
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Mastectomy surgery.

Interventions

Patients will be randomly divided into 2 groups of 25 people, including haloperidol 2 mg intravenously in the amount of 1 cc and the other group of ondansetron 4 mg IV 1 cc. These drugs will be inject

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 60 Years

Inclusion criteria

Inclusion criteria: All candidate patients for bilateral mastectomy 2 side ASA class 1 and 2 patients All patients with general anesthesia Patients aged 35-60.

Exclusion criteria

Exclusion criteria: Duration of surgery more than 150 minutes Parkinson's disease Patients with a history of psychiatric disorders History of chemotherapy and radiation therapy History of nausea and vomiting in previous surgeries Having a movement disorder patient with a history of malignancy Patients with prolonged QT interval Use of opioids, sedatives, or any type of analgesic within one week before mastectomy History of alcohol consumption History of drug abuse

Design outcomes

Primary

MeasureTime frame
The primary outcomes of the study are the incidence of postoperative vomiting. Timepoint: The severity of nausea and vomiting of patients at the beginning of recovery and also at time intervals of 6 hours and 42 hours after surgery. Method of measurement: It will be measured by VAS.

Secondary

MeasureTime frame
Number of times vomiting. Timepoint: At the beginning of recovery and also at time intervals of 6 hours and 42 hours after surgery. Method of measurement: It will be available to patients in recovery based on the VAS criteria.;Severity of postoperative nausea. Timepoint: At the beginning of recovery and also at time intervals of 6 hours and 42 hours after surgery. Method of measurement: The severity of nausea is collected by the number shown by the patient on the ruler.;Time of first vomiting. Timepoint: At the beginning of recovery and also at time intervals of 6 hours and 42 hours after surgery. Method of measurement: Patients who have reached the stage of vomiting are recorded.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamad Noorizad

Iran University of Medical Sciences

samad.noorizad@yahoo.com+98 21 86701

Outcome results

None listed

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