Comparison of efficacy of two drugs in combination for spinal anaesthesia in aged patients undergoing hip surgery

Comparative Efficacy of Hyperbaric Bupivacaine With Fentanyl and Hyperbaric Ropivacaine With Fentanyl in Terms of Haemodynamic Stability and Block Characteristics in Elderly Patients Undergoing Elective Hip Hemiarthroplasty: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091084

Enrollment

Registered

2025-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: S720- Fracture of head and neck of femur

Interventions

Intervention1: Intrathecal 0.75 % hyperbaric ropivacaine 15mg with 25mcg of fentanyl: 15mg of 0.75% hyperbaric ropivacaine with 25mcg of fentanyl is administered intrathecally for spinal anaesthesia f

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing elective hip hemiarthroplasty 2)Patients belonging to ASA II - III

Exclusion criteria

Exclusion criteria: 1)Patients refusal for spinal anaesthesia 2)History of allergy to study drugs 3)Any contra indication for spinal anaesthesia 4)Any severe systemic disorder 5)Patients with impaired hearing and known cognitive impairment 6)Morbid Obesity 7)Patients with poly trauma

Design outcomes

Primary

Measure	Time frame
To compare total dose of phenylephrine required intra operatively to maintain haemodynamic stability in two groupsTimepoint: 4 hours , 5 hours	—

Secondary

Measure	Time frame
Intra operative haemodynamic changes Timepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Onset & duration of motor blockadeTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Pain using NRSTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Incidence & severity of PONVTimepoint: 5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively;Adverse reactions related to fentanylTimepoint: 5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively;Other adverse intra operative events including ECG changesTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min	—

Measure

Time frame

Intra operative haemodynamic changes Timepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Onset & duration of motor blockadeTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Pain using NRSTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min;Incidence & severity of PONVTimepoint: 5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively;Adverse reactions related to fentanylTimepoint: 5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively;Other adverse intra operative events including ECG changesTimepoint: 1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min

—

Countries

India

Contacts

Public ContactDr Bala Subramanya H

Ballari Medical College and Research Centre

halsanadu@gmail.com9980600724

Outcome results

None listed

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