Interest of the Pleth Variability Index in Neurosurgery

National Institute of Neurology, Tunisia

Status: Completed

Conditions: Intraoperative Monitoring; Hypovolemia; Fluid Challenge

Treatments: Other: perioperative fluid responsiveness with the Pleth variability index; Other: perioperative fluid responsiveness with delta PP

Study type: Interventional

Funder types: Other

Identifiers

NCT06624891

PVI IN NEUROSURGERY

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Non-consenting patients
2. Patients classified ASA IV or higher
3. Cardiac arrhythmia
4. Heart disease with left ventricular ejection fraction less than 45%
5. Obesity with a BMI greater than 40 Kg/m2.
6. Peripheral vascular disease
7. Severe lung disease
8. End-stage renal disease
9. Intraoperative cardiac arrhythmia
10. The occurrence of cardiac arrest
11. The occurrence of hemorrhagic shock
12. Intraoperative use of low tidal volumes or high respiratory rates.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

pleth variability index (PVI)

Experimental group

Description:

Participants will be monitored during the intervention using a Radical-7 Pulse CO-Oximeter to instantly determine the pleth variability index (PVI). If the PVI is more than 14% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes.

Treatment:

Other: perioperative fluid responsiveness with the Pleth variability index

delta PP

Active Comparator group

Description:

Participants will be monitored during the intervention using arterial catheter to instantly determine delta PP. If Delta PP is more than 13% for at least 5 minutes, 250 ml of gelofusine solution will be given over 10 minutes.

Treatment:

Other: perioperative fluid responsiveness with delta PP