Effect of noise cancellation on the induction dose of propofol using closed-loop anaesthesia delivery system in patients presenting for non-cardiac surgeries: prospective randomized non-inferiority clinical trail.

The noise exposure in the hospital  influences several patient outcomes and adverse outcome includes tachycardia and blood pressure increased anxiety and incidence of arrhythmias, These effects are shown to happen in the peri-induction and emergence phases of anesthesia and increased noise can potentially worsen them. Our study’s aim is to eliminate the noise exposure to the patients in the OT by using the noise cancellation headphones. We hypothesize that noise cancellation with CLADS will reduce the propofol dosage required for the induction when compared with conventional CLADS. The study is prospective randomized, non-inferiority clinical trial with open label and blinding to data analyst. Our participants are ASA 1 And 2 patients reporting to Nehru hospital and Nehru Hospital Extension Operation Theatres, PGIMER for non-cardiac surgeries. The primary outcome is the difference in the propofol dosage used for induction (BIS 50) between Quiet CLADS (noise) cancellation + CLADS) and conventional CLADS. The secondary outcome includes estimated effect site concentration of propofol, Time required to achieve BIS 50, total propofol dose used, incidence of hypertension, tachycardia during intubation, incidence of hypotension, bradycardia, and their respective rescue medication and the recovery time during intraoperative period. In postoperative period PONV, NRS pain and CAM ICU scores are collected at 30 minutes, 6th, 12the 24th hour. The patient is taken inside the OT with noise-canceling headphones attached. Standard monitors attached with BIS monitoring and the patient is induced with CLADS (fentanyl and propofol). The headphones are removed before the skin closure. The intraoperative and postoperative outcomes are noted as per the above-mentioned protocol.