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

Determining the prophylactic effect of haloperidol compared to ondansetron on the incidence of postoperative nausea and vomiting in patients undergoing bilateral mastectomy

This clinical trial study with a control group, . The rand function of Excel software was used for randomization.

This is a double-blind clinical trial conducted on 50 patients who are candidates for bilateral mastectomy and present to Hazrat Fatemeh Hospital.

Inclusion criteria: ASA class 1 and 2 patients 53–60-year-old patients Inclusion criteria: The duration of the surgery is more than 150 minutes. Parkinson's disease Patients with mental problems History of chemotherapy and radiation therapy History of nausea and vomiting in previous surgeries History of alcohol or drug use.

Patients will be randomly divided into 2 groups of 25 people including the haloperidol group (2 mg IV, 1 cc) and the ondansetron group (4 mg IV, 1 cc). The injection of these drugs will be done after mastectomy.

The primary outcome of the study is the incidence of postoperative vomiting.

In this study, 50 candidates for elective mastectomy, which will be performed due to emotional reasons, are divided using simple randomization. Patients will be divided into two groups (A and B) through simple randomization using a table of random numbers, and patients and researchers will not be informed of the intervention group of each patient. Bilateral non-emergency mastectomy candidates referred to Hazrat Fatemeh Hospital after obtaining informed consent. They enter the study. After the approval of the anesthesiologist, they enter the operating room. All patients are fully monitored including oxygen saturation (SpO2), heart rate (PR), blood pressure (BP), non-invasive blood pressure (NIBC), ECG and temperature measurement. The body will be placed.

Patients will enter the study after obtaining informed consent, but none of them will be aware of the medication they are receiving. After surgery, patients will be recovered and questionnaires including questions related to nausea and vomiting, and patient's hemodynamic parameters will be completed for patients. All patients with vomiting scores of 2 and <5 will be treated with Plazil 01 mg. The severity of nausea and vomiting of patients at the beginning of recovery and also at 6 and 42 hours after surgery will be measured by VAS. It will be available to the patients in recovery, which is collected based on the VAS criteria and the expression of the severity of nausea with the number that the patient shows on the ruler, also the patients who have reached the stage of vomiting are recorded and finally, the data obtained by the analyzer that It is not part of the research team and it is not in the course of the study.