HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorShaheed Mohtarma Benazir Bhutto Institue of Trauma

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A : Spinal Anaesthetic Dose

    Drug

    Participants 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

    Drug

    Participants 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

104 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
2

BRADYCARDIA

It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery

Time frame
Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
3

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.

Time frame
Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade
4

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.

Time frame
Subsequent to the administration of spinal anaesthesia till the end of sensory blockade

Secondary outcomes

Other outcomes

Sponsors and contacts

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