Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06583213

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
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
60 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREFractional Spinal Anaesthesia.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. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).
PROCEDUREConventional Spinal AnaesthesiaIntrathecal 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 five minutes up until 45 minutes.

Timeline

Start date
2024-09-01
Primary completion
2025-10-01
Completion
2025-10-01
First posted
2024-09-03
Last updated
2025-02-25

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06583213. Inclusion in this directory is not an endorsement.