About this trial
The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are:
1. Does height-based spinal anaesthetic dosing reduce the risk of hypotension and bradycardia during surgery as compared to conventional fixed dosing? 2. Does it improve anaesthetic outcomes, such as the onset and duration of sensory and motor block?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Group A : Spinal Anaesthetic Dose
DrugParticipants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally
Group B : Conventional Dose
DrugParticipants will receive 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone intrathecally
Treatment groups
Trial outcomes
Primary outcomes
HYPOTENSION
Defined as a decrease of ≥20% in mean arterial pressure (MAP) from baseline or an absolute MAP \<65 mmHg at any point during surgery, recorded using non-invasive blood pressure monitoring at five-minute intervals
BRADYCARDIA
It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery
ONSET OF SENSORY BLOCK
It will be defined as the time interval (in minutes) from the completion of intrathecal injection of bupivacaine to the loss of pinprick sensation at the T10 dermatome. The assessment will be carried out using a sterile blunt 23-gauge needle at one-minute intervals until loss of sensation is confirmed.
DURATION OF SENSORY BLOCK
It will be defined as the time interval (in minutes) from the onset of sensory block at the T10 dermatome (confirmed by loss of pinprick sensation) to the reappearance of sensation at the same dermatome level. The response will be assessed every 5 minutes using a sterile blunt 23-gauge needle.
Sponsors and contacts
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