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Clinical Trials/NCT06624891
NCT06624891
Completed
Not Applicable

Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index

National Institute of Neurology, Tunisia1 site in 1 country70 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Monitoring
Sponsor
National Institute of Neurology, Tunisia
Enrollment
70
Locations
1
Primary Endpoint
Value of PVI in fluid responsiveness in neurosurgery
Status
Completed
Last Updated
last year

Overview

Brief Summary

This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.

The main question it aims to answer is:

• Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.

Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
August 19, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Neurology, Tunisia
Responsible Party
Principal Investigator
Principal Investigator

Hammami Rabeb

university hospital assistant

National Institute of Neurology, Tunisia

Eligibility Criteria

Inclusion Criteria

  • Patients proposed for intracranial surgery
  • Must be aged 18 and over
  • Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification

Exclusion Criteria

  • Non-consenting patients
  • Patients classified ASA IV or higher
  • Cardiac arrhythmia
  • Heart disease with left ventricular ejection fraction less than 45%
  • Obesity with a BMI greater than 40 Kg/m
  • Peripheral vascular disease
  • Severe lung disease
  • End-stage renal disease
  • Intraoperative cardiac arrhythmia
  • The occurrence of cardiac arrest

Outcomes

Primary Outcomes

Value of PVI in fluid responsiveness in neurosurgery

Time Frame: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery

Investigate the value of the plethysmographic variability index (PVI) in assessing the response to perioperative vascular filling in neurosurgery.

Secondary Outcomes

  • Amount of fluids administered intraoperatively(during the surgery)
  • Renal, metabolic and hydroelectrolytic repercussions.(up to the first 24 hours postoperatively)
  • Length of postoperative stay(up to hospital discharge, an average of 4 days)
  • Incidence of post-operative complications(up to hospital discharge, an average of 4 days)

Study Sites (1)

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