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NCT Number: NCT06583213

Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

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

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hip fractures.
  • Patients age >60 years old.
  • ASA ≤ 3. Patients with a CFS score ≥5

Exclusion criteria

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

Treatment and study plan

Fractional Spinal Anaesthesia.

Procedure

An intrathecal catheter 20 G will be then inserted 2-3 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 12 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).

Conventional Spinal Anaesthesia

Procedure

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 ). (Mohamed T et al., 2017).

Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every minute up to 30 minutes.

Primary outcomes

  1. Is to measure blood pressure change intra-operative operative operative (2 hours)

    Time frame: 2 hours

    blood pressure monitoring

Secondary outcomes

  1. Postoperative pain score for 24 hours

    Time frame: within 24 hours

    pain score using the Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparative Study Between Conventional Spinal Anaesthesia and Fractional Spinal Anaesthesia on Systemic Haemodynamics in Frail Elderly Hip Fracture Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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