Intraoperative comparison and evaluation of intrathecal bupivacaine combined with clonidine versus fentanyl in children undergoing hernia repair or genital surgery: A prospective, randomized controlled trial

Background: Nowadays, spinal anesthesia is commonly being used in infants and children for infraumblical surgeries. Intrathecal adjuvants such as clonidine and fentanyl are used with local anesthetics for additive effects. Aim: The present study aims to assess and compare the effects of adding clonidine versus fentanyl to bupivacaine intrathecally in terms of propofol consumption, hemodynamic profile, adverse events, and complications intraoperatively in pediatric patients. Settings and Design: A prospective randomized controlled trial was conducted between June 2016 and October 2018 in pediatric patients aged 3-8 years undergoing hernia repair or genital surgery under spinal anesthesia after approval of the Institutional Ethical Committee (Reference No: SGRR/IEC/04/16). Materials and Methods: Patients were randomly divided into two equal sized (n = 42) study groups, while analysis was done in (n = 40) each group. Group 1 (BC) received clonidine 1 μg/kg with 0.5% bupivacaine (heavy) and Group 2 (BF) received fentanyl 0.5 μg/kg with 0.5% bupivacaine (heavy). Statistical Analysis: Quantitative data were expressed in mean and standard deviation. Qualitative data were expressed in proportion and percentages. Independent t-test was applied to compare the means of quantitative data, and Chi-square test was used to compare categorical data. P < 0.05 was considered statistically significant. Results: Patient characteristics regarding age, weight, and surgical time were comparable in the two groups. The maintenance dose and bolus dose of propofol consumed during surgery were less in Group 1 than that in the Group 2 and were found to be statistically insignificant. The values of hemodynamic parameters such as heart rate, systolic blood pressure, and diastolic blood pressure were less in Group 1 and were statistically significant at different time intervals. Sedation scores were comparable in both groups. Intraoperative incidence of bradycardia, systolic hypotension, and diastolic hypotension were high in Group 1, whereas the incidence of desaturation was high in Group 2. Intraoperative complications such as apnea and respiratory obstruction were high in Group 2, but were statistically insignificant. Conclusion: We conclude that intrathecal adjuvant fentanyl maintains a better hemodynamic profile in terms of adverse events such as bradycardia, systolic hypotension, and diastolic hypotension. Intrathecal clonidine maintains a better sedation level requiring less propofol for sedation. Complications such as apnea and respiratory obstruction can be attributed more to the deep sedation caused by bolus of propofol rather than the inherent properties of intrathecal adjuvant clonidine or fentanyl.