Comparison of fentanyl and clonidine as adjuvants to intrathecal 1% chloroprocaine in infra-umbilical surgeries-A randomized comparative trial

Our research work and study was conducted in the “Department of Anesthesiologyâ€, Rohilkhand Medical College and Hospital, following approval by the Board of Institutional Ethics Committee (IEC/04/2020/OCT) and registration of the study with Clinical Trial Registry of India (CTRI/2021/02/031470), with the objective to compare the efficacy of intrathecally administered fentanyl and clonidine as adjuvants to 1% chloroprocaine, in patients posted for elective infra-umbilical surgeries.

In our study a total of 64 patients were included which were statistically calculated using the software Power and sample size program35. The sample size was calculated as 32 in each group.35

⮚ Group C: patients were scheduled to receive 1% Isobaric Chloroprocaine 3 ml (30mg) + clonidine (30 mcg), i.e. 0.2 ml after dilution with 0.3ml of 0.9% normal saline. Total volume = 3.5ml

⮚ Group F: patients were scheduled to receive 1% chloroprocaine 3ml (30 mg) + fentanyl (25 mcg), i.e. 0.5 ml. Total volume = 3.5ml

In our study, there was no statistically significant difference (p>0.05) in demographic profile (age, weight, gender) among the groups showing comparability of the groups in respect of age, weight and gender. The mean time of onset of sensory and motor block was statistically insignificant among the groups (p>0.05). The maximum peak height achieved in both Groups was up to T6 level and these observations were statistically non-significant (p>0.05). In our study, time for 2 segment regression was observed to be earlier in group of patients who got spinal anaesthesia with Chloroprocaine along with Fentanyl. The mean duration of sensory blockade was statistically significant (p<0.001) when compared between two groups and prolonged in the group who received Chloroprocaine with Clonidine intrathecally. Onset of motor block was comparable in both clonidine and fentanyl groups and were statistically insignificant (p>0.05). But, when compared with plain local anesthetics, addition of adjuvants has shown earlier onset (as per several other studies). In our study we found mean time of total duration of motor block prolonged in group of patients who received clonidine as an adjuvant to intrathecal chloroprocaine. As per several studies, when compared with plain local anesthetics, addition of adjuvants has shown prolonged duration of sensory as well as motor block. While clonidine as an adjuvant gave longer duration of sensory as well as motor blockade than that of fentanyl as an adjuvant to intrathecal chloroprocaine or other local anesthetics. Patients who received fentanyl as an adjuvant to intrathecal chloroprocaine were found to be more hemodynamically stable in intra-operative period than in patients who received clonidine as an adjuvant to intrathecal chloroprocaine. Few patients in both the groups had episodes of hypotension and bradycardia which was managed well as per study protocol. Transient neurological symptoms, respiratory depression and pruritis was not seen in any of the groups. Our observations on side effects were found to be statistically insignificant (p>0.05) on comparison between both groups. Patients in fentanyl group were found to be more hemodynamically stable in intra-operative and post-operative period than in clonidine; but lesser side effects like PONV (post operative nausea and vomiting), shivering etc. was seen in patients who received clonidine as an adjuvant to intrathecal chloroprocaine.