The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.

NCT05991063 | Unknown

• 1 other identifier: Ms2022
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Many previous studies have investigated the ability of various methods such as passive leg raising test , and inferior vena cava collapsibility index in predicting post-spinal hypotension, but none of them have succeeded in obtaining a good predictive value. Our study aims to combine the passive leg raising test with the inferior vena cava distensibility index to aid in predicting post-spinal hypotension in elderly undergoing infra-umbilical surgeries.

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.

  The incremental changes of measured maximum inferior vena caval diameter after passive leg raising

  15 minutes before spinal anesthesia

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 68 consecutive elderly patients, aged \>65 years scheduled for elective infra-umbilical surgical operations under spinal anesthesia will be included in the study.

You may qualify if:

• \. 65 years of age or more. 2. ASA score I \& II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia.

You may not qualify if:

• Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as orthostatic hypotension, syncopal attacks, decreased sweating, and urinary incontinence) Emergency operations Absolute contraindications or failure to perform spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or possibly unreliable ( venous compression stocking, intraabdominal hypertension) Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric gas interferin

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08