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Comparison of Fractionated versus Bolus Spinal Anaesthesia in Elderly Surgical Patients

Comparison of Haemodynamics Between Fractionated and Bolus Injection in Spinal Anaesthesia for Elderly Patients: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098509
Enrollment
100
Registered
2025-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: M844- Pathological fracture, not elsewhere classified

Interventions

Intervention1: Fractionated intrathecal injection of 0.5% hyperbaric bupivacaine with fentanyl: A total of 3 ml intrathecal anaesthetic solution (2.5 ml of 0.5% hyperbaric bupivacaine + 0.5 ml fentany

Sponsors

Dr Mohanapriya S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age Above 65 Years 2 ASA Grade I,II,III 3 Patient Consent

Exclusion criteria

Exclusion criteria: 1 CONTRAINDICATION TO SPINAL ANAESTHESIA 2 CARDIOVASCULAR DISEASES( ISCHEMIC HEART DISEASE) 3 CEREBROVASCULAR DISEASE 4 SPINE TO DEFORMITIES 5 ALLERGY TO STUDY DRUGS

Design outcomes

Primary

MeasureTime frame
Incidence of Hypotension MAP LESS THAN 65 mmHg OR MORE THAN OR EQUAL TO 20 PERCENTAGE fall from baseline Incidence of Bradycardia HR LESS THAN 60 bpm OR MORE THAN 20 PERCENTAGE fall from baselineTimepoint: Every 2 minutes for first 10 minutes,Then every 5minutes for next 2 hours and then every 15 minutes for next 4 hours upto 24 hours postoperatively Every 5 minutes for next 2 hours Every 15 minutes for next 4 hours Every 4 hours up to 24 hours postoperatively Every 2 minutes for first 10 minutes Every 5 minutes for next 2 hours Every 15 minutes for next 4 hours Every 4 hours up to 24 hours postoperatively

Secondary

MeasureTime frame
1 onset of sensory block time from completion of spinal injection T10 dermatomes 2 onset of motor block time from completion of spinal injection to achieving modified bromage score 3 3 two segment regression time time from maximum sensory level attained to regression by two dermatomes 4 maximum sensory level attained 5 total vasopressor requirement number of IV phenylphrine 20 microgram boluses required 6 block characteristics duration of sensory & motor block & total duration of anaesthesia 7 adverse events & complication nausea vomitting shivering giddinessTimepoint: 1 continuously assessed immediately after injection until T10 is reached upto end of surgery 2 continuously assessed until bromage 3 is reached intraoperatively 3 assessed periodically regression occurs 4 max sensory level attained every 10mins upto 24 hours 5 from onset of block until the end of surgery 6 intraoperative postoperative period upto 24 hours 7 intraoprative & up to 24 hours postoperatively

Countries

India

Contacts

Public ContactDr Venkatraman

SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

drvenkat94@gmail.com9894581455

Outcome results

None listed

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