Comparison of neonatal complications and Apgar score in mothers under spinal anesthesia for conventional and low doses of bupivacaine and fentanyl

Comparison of neonatal complications and Apgar score in mothers under spinal anesthesia for conventional and low doses of bupivacaine and fentanyl

Clinical trial with control group, parallel groups, double blind, randomized, phase 3, 150 patients

A total of 150 pregnant women which referred to Shohadaye Kargar hospital in Yazd included to the study. All patients received one liter of ringer serum before spinal anesthesia. Then, in sitting position in L3-L4 space, spinal anesthesia with needle number 25 performed. In the placebo group, 15 mg bupivacaine injected with 0.5 ml of 1% normal saline, and in the study group, 12.5 mg bupivacaine injected with 0.5% fentanyl 25% intrathecally. For both groups, Neonates' apgar score assessed at specified times and complications such as nausea and chills and the results recorded in a questionnaire.

Inclusion criteria: All ASA Class 1 female patients underwent non-emergency cesarean section. Exclusion criteria: Eclampsia, preeclampsia, gestational diabetes, hypertension, emergency cesarean section, preeclampsia, acute and chronic fetal distress, under 18 years of age, body mass index more than 40, psychiatric and neurological diseases, drug allergy, addiction to illegal drugs and psychotropics.

Placebo group: 15 mg bupivacaine 0.5% hyperbaric plus 1 cc normal saline Case group: 12.5 mg bupivacaine 0.5% hyperbaric with 25 μg fentanyl

Side effects of medication, neonatal apgar score

We used the permuted block randomization method, and these blocks were randomly designed in Excel software, and then groups equal to the allocation of a as the intervention group and b as the control group were performed.

Statistical analyser and outcome assesor were blinded in the study and were unaware of how patients were placed in the study groups.

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