Spinal-Induced Hypotension in Geriatric Patients

NCT05862298 | Completed DMC

• 1 other identifier: postspinal hypotension
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted to asses preoperative condition of venous system by VExUS score and it's relation with the incidence of spinal induced hypotension in geriatric patients undergoing surgery with spinal anaesthesia.

Conditions

Spinal Induced Hypotension; Geriatric Population; Intravascular Volume

Outcome Measures

Primary Outcomes (1)

• venous excess ultrasound score

  score used to assess venous circulation

  immediate preoperative period before the induction of spinal anesthesia

Interventions

venous excess ultrasound score DIAGNOSTIC_TEST

Venous congestion is classified into 4 grades. If the Inferior vena cava is not plethoric, there is deemed to be no congestion (grade 0), and further Doppler examination is not performed. When the IVC is plethoric but there are no severely abnormal waveforms (defined as S-wave reversal on hepatic, \>50% pulsatility on portal, and a monophasic pattern on intrarenal Doppler), congestion is considered to be mild (grade 1). Plethoric IVC with at least 1 severely abnormal pattern is considered to be moderate congestion (grade 2), while 2 or more abnormal Doppler patterns constitute severe congestion (grade 3)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

geriatric patients aged greater 65 years scheduled for Lower body surgeries under spinal anaesthesia with BMI less than 30 kg/m2 with ASA I-III. These populations are high susceptible for development of spinal induced hypotension with high incidence of morbidity and mortality

You may qualify if:

• Patients aging 65 or older
• Lower body surgeries to be done with spinal anaesthesia
• BMI less than 30 kg/m2.
• Patients with ASA I-III

You may not qualify if:

• Patient refusal
• Major bloody surgeries (class c surgeries)
• Patients with a history of cardiovascular disorders including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, AF
• Patients with a history of respiratory disorders
• Patients with cirrhotic liver
• Patients with pulmonary hypertension
• Patients with renal diseases

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

tarek Abdelhay Mostafa

Tanta, El Gharbyia, 31111, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: May 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

EG (1)