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Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06583213
Enrollment
44
Registered
2024-09-03
Start date
2024-09-01
Completion date
2025-05-01
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

fractional spinal

Brief summary

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

Detailed 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.

Interventions

PROCEDUREFractional Spinal Anaesthesia.

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 ).

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Is to measure blood pressure change intra-operative operative operative (2 hours)2 hoursblood pressure monitoring

Secondary

MeasureTime frameDescription
Postoperative pain score for 24 hourswithin 24 hourspain score using the Visual Analogue Scale

Countries

Egypt

Contacts

STUDY_DIRECTORahmed saudi, professor

Ain Shams University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026