Comparison of the effect of prophylactic injection of doses of 4 and 8 mg of intravenous Ondansetron on nausea and itching after spinal injection of Fentanyl in spinal anesthesia, in lower limb orthopedic surgery

Comparison of the effect of prophylactic injection of doses of 4 and 8 mg of intravenous Ondansetron on nausea and itching after spinal injection of Fentanyl in spinal anesthesia, in lower limb orthopedic surgery

A controlled, parallel-group, triple-blind, randomized, phase 2 clinical trial on 90 patients. The lottery is used for randomization

This is a three-blind randomized clinical trial that will be conducted on 90 patients candidate for orthopedic surgery under spinal anesthesia in Kashani Hospital, Isfahan. After the approval of the ethics committee and obtaining the consent of the patients, the patients are randomly assigned into groups, in each group the desired intervention is applied and the clinical symptoms of the patient are recorded. The researcher who records the patient's symptoms, the analysts who collect the data analyzed during the study, and the patients did not know the type of intervention applied in each group, so they were all blind.

Inclusion criteria: age 18 to 65 years, ASA anesthesia class I and II, candidate for lower limb orthopedic surgery under spinal anesthesia, and consent to participate in the study. Non-Inclusion criteria: addiction to cigarettes, narcotics, and psychotropic substances, allergy to any of the drugs used, presence of skin infection at the injection site, anti-nausea use in the last 24 hours, pregnancy and breastfeeding

Intervention group A: Patients in this group receive 8 mg of ondansetron (equivalent to 4 ml) intravenously 30 minutes after spinal. Intervention group B: Patients in this group receive 4 mg of ondansetron (equivalent to 4 ml) intravenously 30 minutes after spinal. Control group C: Patients in this group receive 4 mg of 4 ml of distilled water intravenously 30 minutes after spinal

nausia, itching

This is a simple randomized clinical trial in which patients entered the study groups by lottery; The medicines and placebo are placed in sealed, opaque, and similar form packets coded. Each code is also written on a piece of paper, folded, and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box; The pocket with the same number is the intervention that will apply to him. This process continues till the number of patients will reach the desired one.

This is a three-way blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the person who injects the drug and has no knowledge of the type of drug and is blind. The analysts who analyze the data collected during the study also don't know the type of intervention in any group and they are blind. Even though the patients are included in the study, they do not know the type of intervention and are blind.