1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sayak.howwrah@gmail.com].
   


6. For how long will this data be available start date provided 20-12-2025 and end date provided 20-05-2030?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Spinal anaesthesia is a technique involving the introduction of local anaesthetics into the subarachnoid space. Currently, bupivacaine, a long-acting local anaesthetic, is the agent of choice for spinal anaesthesia. Although bupivacaine provides dense motor and sensory block, it can be associated with significant cardiovascular side effects, particularly hypotension and bradycardia. Ropivacaine, another long-acting anaesthetic like bupivacaine, is becoming a popular alternative. It, reportedly has fewer cardiovascular side effects and is more selective for blockage of sensory fibres than motor and autonomic fibres. This property allows patients to regain mobility sooner, reduces urinary retention, and even makes spinal anaesthesia feasible for same-day discharge after surgery.

In the proposed randomized controlled trial, we aim to evaluate the haemodynamic stability of isobaric (0.75%) ropivacaine versus hyperbaric (0.5%) bupivacaine (control) for subarachnoid block in patients undergoing transurethral resection of prostate. The study will be carried out in 100 subjects divided into two groups of 50 each as bupivacaine and ropivacaine group. We will administer 2 ml of equipotent dose of the respective drug (10 mg of bupivacaine or 15 mg of ropivacaine) in each group and record their haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) using standard multipara monitor with appropriate sized (bladder length 80% of the patient’s arm circumference, and the bladder width >= 40% of the arm circumference) non invasive blood pressure cuff every 5 min for the intraoperative period, then every 15 min in postoperative period for 3 hours total. Hear rate will be monitored continuously and recorded as an average of last 4 secs every 5 min the intraoperative period, then every 15 min in the postoperative period for 3 hours total. Our objective is to compare the haemodynamic effects in the intraoperative period.

By comparing the haemodynamic effects of these drugs, we can make more informed decisions to minimize complications associated with spinal anaesthesia.