Effect of music therapy with noise cancellation versus dexmedetomidine infusion on quality of recovery among patients undergoing lower limb arthroplasty under regional anaesthesia: A randomized non-inferiority trial.

After approval from the Institutional Ethics Committee, PGIMER, Chandigarh, written informed consent will be obtained from all the patients before enrolment in this randomized control study. Pre anaesthetic evaluation • All the patients will undergo standard pre-anaesthetic exam. The patients who meet the inclusion criteria will be included in the study. • The procedure will be explained to the patient and consent will be taken. Before spinal anaesthesia • Fasting of the patient will be confirmed. • 104 patients will be randomly divided into group M (music) or group D (dexmedetomidine) in a 1:1 ratio using a computer-generated list concealed by sealed opaque envelopes. • Baseline QoR-15 score will be done. Patient will be asked to choose the type of music from a list of pre-made instrumental playlists. • Once the patient enters the operating room, they will be asked to lie supine on the operating table. ASA standard monitors will be attached, a warming device will also be attached. IV access will be taken and the patient will receive maintenance fluid with Ringer Lactate or Normal Saline. • Baseline vitals (HR, SpO2, SBP, DBP, MAP) will be recorded. Noise level in the operating room will be recorded continuously throughout the procedure. • Under appropriate aseptic precautions, in the sitting position, the patient’s back will be painted with an antiseptic solution and draped. • The antiseptic solution will be left to dry for a few minutes. Meanwhile, the drug (Heavy Bupivacaine 10mg + Fentanyl 25 mcg) will be loaded in a syringe for intrathecal injection in a sterile manner. • L3-L4/L4-L5 intervertebral space will be identified using Tuffier’s line as a landmark that passes from the highest point on the iliac crests. • 18G Tuohy’s needle will be used to enter the epidural space using the loss of resistance technique. Epidural catheter will be inserted and fixed. • A test dose of 3ml of Lignocaine-Adrenaline mixture (150 mcg of Adrenaline in 30 ml of lignocaine) will be injected in the epidural catheter and vitals will be observed. • 25G/26G Quincke’s spinal needle will be used through either the midline approach or the paramedian approach. The needle will be inserted in the intervertebral space between L3-L4 vertebrae or L4-L5 vertebrae. • After the free flow of CSF is seen, the syringe will be locked tightly to the spinal needle, and the drug will be administered intrathecally to the patient in the L3-L4 or L4-L5 intervertebral space. • The patient will be asked to lay supine as the drug settles. Blood pressure will be taken every 2 minutes for 10 minutes. Then the frequency will be decreased to every 5 minutes, continuing in this pattern until 30 minutes have elapsed since the injection of the spinal drug and thereafter recorded every 15 minutes. After spinal anaesthesia • The highest sensory and motor block levels will be recorded along with HR, SBP, DBP, MAP and SpO2. • Patients in group M will have active noise cancellation (ANC) headphones placed over their ears with their previously chosen playlist playing. The playlist will loop automatically. • Patients in group D will be sedated using IV dexmedetomidine at 0.5 mcg/kg over 10 minutes followed by 0.5 mcg/kg/hour for maintenance. • Rescue sedation of 1mg Midazolam IV bolus will be given to patients of both groups at their request until RASS -1 to +1. • Noise levels (in decibels) will be continuously recorded using a mobile app in the operating room throughout the procedure. The same device will be used to measure noise levels for all cases. Post operative • An epidural infusion will be attached to the patient for 48 hrs containing 240 ml of 0.125% bupivacaine at 5ml/hour. • 24 hr post-operative QoR-15 score will be assessed. Patient satisfaction, anxiety, frequency of PONV, sedation, pain and analgesic requirements will be assessed.