Evaluation of Prophylactic ondansetron in prevention of maternal hypotension following spinal anesthesia in women undergoing cesarean section

Study of the efficacy of intravenous ondansetron in prevention of hypotension following spinal anesthesia in women undergoing cesarean section

This is a controlled double-blinded clinical trial study will be conducted on 60 women undergoing cesarean section with spinal anesthesia. After coordination and obtaining informed consent, the patients (n=30per group) will be randomly assigned into two groups of intravenous ondansetron (10 mg) or normal saline at the same dose and will be received the medications before spinal anesthesia.

From pregnant women candidate for cesarean section with spinal anesthesia referring to Imam Khomeini hospital, Ahvaz, total of 30 patients will be selected and randomly divided into 2 groups. In the first group, ondansetron10 mg will be injected intravenously before spinal anesthesia. In the second group, normal saline 10 mg will be used. The patients and experimenters will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.

- Inclusion criteria: age between 18 to 40 years, Candidate for elective cesarean section, no contraindication for spinal anesthesia, Consent to participate in the study; Exclusion criteria: Hypertension, weight more than 100 kg, motion sickness, cardiovascular disease, liver disease, migraine, allergy to ondansetron medications group, using any medication which effect the blood pressure or heart rate.

In the first group, ondansetron 10 mg will be injected intravenously before spinal anesthesia. In the second group, normal saline 10 mg will be used as control.

All patients will be examined for Hemodynamics change (HR, SBP, DBP) and side-effects after surgery (nausea, vomiting, chills, itching) up to 2 hours after the patient entry to recovery.

Patients will be randomly assigned into two groups of experimental and control. Each patient is given a number from 1 to 60 and assignment of patients into the study groups will be done by table of random numbers.

Intervention (receiving normal saline orondansetron) and patient evaluation will be carried out by a physician who is blinded to both treatment groups. Also patients and statistical analyzer will not know about patient grouping.