Skip to content

Comparing the hemodynamic stability of Ropivacaine and Bupivacaine in frail elderly patients undergoing Prostate surgery under Spinal anaesthesia

A Randomized controlled trial to assess the hemodynamic stability in frail elderly patients using 0.75 percent hyperbaric ropivacaine vs 0.5 percent hyperbaric bupivacaine undergoing Trans Urethral Resection Of Prostate surgery under spinal anaesthesia. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081402
Enrollment
80
Registered
2025-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Drug - Local Anaesthetic: 0.75% hyperbaric Ropivacaine volume 2.5 ml, single dose, intrathecal administration, single time intervention at the time of the surgery. Control Intervention

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 60 years and above who have been assessed fit for TURP surgery under ASA II and ASA III 2.Patients with an Edmonton Frail Scale (EFS) score greater than 6, indicating frailty and vulnerable frailty. 3.Patients who provide informed written consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patients with contraindications to spinal anesthesia, such as allergy to local anesthetics or coagulopathy. 2.Patients with severe cognitive impairment or inability to provide informed consent. 3.Patients with unstable cardiovascular conditions, including recent myocardial infarction, or severe heart failure. 4.Patients with a history of chronic pain management requiring opioid therapy. 5.Patients with a known neurological disorder affecting spinal cord function.

Design outcomes

Primary

MeasureTime frame
TO assess the intra op hemodynamic stabilityTimepoint: every 2 mins for the first 20 mins and followed by every 20 mins until the end of surgery.

Secondary

MeasureTime frame
time to attain more than 9 score in modified bromage scaleTimepoint: every 10 minutes from end of surgery.;time to attain PADDS score more than 9Timepoint: Every 10 minutes from end of surgery;length of hospital stay in daysTimepoint: every day from end of surgery;postoperative complications like delerium and cognitive dysfunctionTimepoint: every 6th hourly till discharge

Countries

India

Contacts

Public ContactMirunaliniG

srm medical college hospital and research centre

mirunalg@srmist.edu.in9486131643

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026