Comparison of target controlled infusion of dexmedetomidine versus conventional dexmedetomidine infusion for awake craniotomy A randomised clinical study

This prospective, interventional, parallel-arm, single-centric randomised controlled study aims to compare the effectiveness of the Hannivoort pharmacokinetic model for target-controlled infusion of dexmedetomidine with the conventional intravenous dexmedetomidine infusion for sedoanalgesia in patients undergoing awake craniotomy. It shall include 50 adult ASA I-II patients of either sex aged 18-70 years, weighing 45-80kg. Exclusion criteria comprise refusal to give consent, local anaesthetic allergy, raised intracranial pressure, bradyarrhythmias, and deranged hepatic function. The study shall be conducted at Rajiv Gandhi Cancer Institute and Research Centre, Delhi. The patients shall be randomly allocated to two groups: conventional dexmedetomidine infusion group (Group C; n = 25),  and target controlled infusion of dexmedetomidine group (Group T; n = 25). Our primary outcome measure would be the pain numeric rating scale (NRS), measured at the time of scalp block, urinary catheter placement, headpins application, skin incision, burr holes, dural incision, cortical mapping, tumour resection, dural closure and skin closure. Our secondary outcome measures shall be anxiety NRS, perfusion index, heart rate, mean arterial pressure, respiratory rate, bispectral index, and observer’s assessment of anxiety/sedation score measured at the above time points. We shall also measure the patient satisfaction score, clinician satisfaction score, and Trieger test score 30 minutes after completion of surgery.