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Clinical Trials/CTRI/2024/11/076358
CTRI/2024/11/076358Not yet recruitingPhase 3

Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia in elderly patients undergoing femur fracture surgery – A randomized double-blind study

Dr Arun Parthasarathy1 site in 1 country118 target enrollmentStarted: November 18, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
118
Locations
1
Primary Endpoint
To compare the hemodynamic stability between fractionated and bolus dose injection in spinal anaesthesia

Study Overview

Brief Summary

The geriatric population, irrespective of the type of surgery they undergo, poses a challenge for the anaesthesiologists. This is attributed to the reduced functional reserve in the elderly, associated multiple comorbidities and frail nature. Elderly patients with femur fractures usually add to this challenge as they may present late to the hospital for their treatment, which increases the risk of perioperative adverse outcomes. Generally, spinal anaesthesia (SA) is commonly employed for lower limb surgeries. Its advantages are simple to perform, good analgesia, reduced blood loss and so on. But the sympatholysis produced by spinal anaesthesia when given as a bolus dose of local anaesthetics can lead to profound hypotension, which may not be tolerated by the elderly patients. This hypotension can predispose patients to have end organ damage, which contributes to the overall morbidity. Rate of injection is one of the factors determing the level of spinal block and incidence of hypotension. Fractionated dose of local anaesthetic in spinal anaesthesia is administering two-thirds of the total calculated dose initially following which the remaining one-third dose is given after a gap of 45 to 90 sec between the injections. This method has been shown to provide better hemodynamic stability and longer duration of analgesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
60.00 Year(s) to 95.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Elective femur fracture surgery, Age more than 60 years, ASA PS 1,2,3, Surgery planned under spinal anaesthesia.

Exclusion Criteria

  • Patient refusal Absolute contraindications for spinal anaesthesia.

Outcomes

Primary Outcomes

To compare the hemodynamic stability between fractionated and bolus dose injection in spinal anaesthesia

Time Frame: Every 3 minutes for the initial 30 minutes

Secondary Outcomes

  • To compare the time of onset and duration of sensory block(To compare the time of onset and duration of motor block)

Investigators

Sponsor
Dr Arun Parthasarathy
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Arun Parthasarathy

Kasturba Medical College, Manipal

Study Sites (1)

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