Comparison of the effectiveness of Atropine-Neostigmine mixture and Ondansetron injection in preventing headache after Cesarean section under spinal anesthesia

Comparison of the effectiveness of atropine-neostigmine mixture injection and ondansetron injection in preventing headache after cesarean section under spinal anesthesia

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Lottery and sealed envelopes are used for randomization.

This is a randomized double-blind clinical trial that will be performed on 60 patients undergoing cesarean section under spinal anesthesia at Beheshti Hospital in Isfahan; After the approval of the university ethics committee and obtaining the patients' consent, the patients entered the groups by random allocation. In each group, the desired intervention is applied and the patient's clinical signs and existing complications are reviewed and recorded. The person who is performing the intervention would be different from the evaluator and they do not know the type of intervention. In spite of the fact that Patients are aware of the study, they are not aware of the type of intervention so they are all blind.

Inclusion criteria: 18 to 45 years old pregnant woman undergoing cesarean section under spinal anesthesia, anesthesia ASA class I and II, and patient informed consent. Exclusion criteria: history of coagulation diseases, presence of nerve damage in limbs, spine, and CNS, history of spinal surgery, MS, and Migraine history.

Intervention group A: They receive a mixture containing 20 µg/kg Neostigmine and 10µg/kg Atropine 15 minutes before the spinal anesthesia. Intervention group B: They Receive 4 mg of ondansetron 15 minutes before spinal anesthesia.Control group C: They receive 5 ml of distilled water 15 minutes before the spinal.

The headache after spinal anesthesia

This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs are placed in the desired number in sealed opaque and uniformly sealed bags. Each of the codes 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. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups.

This is a double-blind clinical trial; In this way, before obtaining consent, patients are studied but do not know which group they will be in and therefore are blind. Also, the nurse who injects the drug and the researcher who records the patient's symptoms do not know the type of drug and are blind.