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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05991063
Other study ID # Ms2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date February 2024

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: - 1. 65 years of age or more. 2. ASA score I & II. 3. Patients are scheduled for infra umbilical surgeries under spinal anesthesia. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms

  • Hypotension
  • Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary The sensitivity of ?max.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
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