Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

Ain Shams University

Status: Enrolling

Conditions: Hip Fractures

Treatments: Procedure: Conventional Spinal Anaesthesia; Procedure: Fractional Spinal Anaesthesia.

Study type: Interventional

Funder types: Other

Identifiers

NCT06583213

FMASU MD76/2024

Details and patient eligibility

About

compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

Full description

Spinal anaesthesia affects sympathetic chain activity, leading to a reduction in vasomotor tone.It was found that the incidence of hypotension following single-shot spinal anaesthesia, has previously been described as being 28-69%. As a matter of fact, autonomic nervous system function plays a key role in the development of haemodynamic instability and intraoperative hypotension . Haemodynamic stability should be considered as a primary intraoperative target, since several findings suggest avoiding systemic pressure drops . It was found that hypotension is primarily related to the overall dose injected ; however, several other variables, including the volume, the type of the anaesthetics injected, different adjuvant agents, and pre- and intraoperative factors, may impact the haemodynamic effect of the SA.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hip fractures.
• Patients age >60 years old.
• ASA ≤ 3.

Exclusion criteria

• Patients on anticoagulant medication.
• Planned for general anaesthesia .
• Patients had atrial fibrillation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Fractional Spinal Anaesthesia. Group A.

Experimental group

Description:

An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min.

Treatment:

Procedure: Fractional Spinal Anaesthesia.

Procedure: Conventional Spinal Anaesthesia

Conventional Spinal Anaesthesia. Group B.

Active Comparator group

Description:

Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.

Treatment:

Procedure: Fractional Spinal Anaesthesia.

Procedure: Conventional Spinal Anaesthesia