Effect of pre-administration with Neostigmine and Atropine on the occurrence of post dural puncture headache in patients undergoing spinal anesthesia in cesarean

Determining the effect of Neostigmine and Atropine on post-dural puncture headache in spinal anesthesia in cesarean

The randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 62 patients

In this randomized double-blind clinical trial study, 62 pregnant women candidate for cesarean section with spinal anesthesia referred to Beheshti Hospital in Isfahan will be included in the study and randomly divided into 2 groups. Neostigmine and atropine will be used in one group and normal saline in the other. Then the severity of patients' headaches is evaluated.

Inclusion criteria include pregnant women candidate for cesarean section with spinal anesthesia, American society of anesthesiologists classification 1 and 2, in the age group of 18 to 45 years, no neurological deficit in limb, spinal cord, no coagulation diseases, no history of spinal cord surgery, spinal canal stenosis and MS, duration of surgery less than 2 hours, no heart conductive disorder, no history of migraine headaches, and patient consent to participate in the study. Exclusion criteria include spinal block failure, change in anesthesia method to general anesthesia bleeding more than 20 cc/kg, and more than 3 punctures.

Intervention group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, patients will be prescribed a combination of 0.5 mg of neostigmine and 0.5 mg of atropine. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously. Control group: All patients will undergo spinal block. After performing the spinal block and confirming its accuracy, normal saline will be prescribed to patients. Thus, for every 10 kg of patient weight, 1 cc is administered intravenously.

Severity of headache; duration of headache

In this study, 62 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.

In this study, the drug combination of "neostigmine and atropine" and normal saline were prepared by the operating room nurse in the same volume and marked with labels A and B. It is then given daily to the researcher and will be administered accidentally for patients. Therefore, the patient and the researcher will not have any information about the two prescribed drugs.

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