Fluid Challenge, Hypovolemia, Intraoperative Monitoring
Conditions
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.
Interventions
OTHERperioperative fluid responsiveness with the Pleth variability index
Perioperative fluid challenge and responsiveness will be based on monitoring the pleth variability index. In fact, volemia will be estimated with the PVI.
OTHERperioperative fluid responsiveness with delta PP
fluid challenge and responsiveness during intervention will be based on monitoring delta PP.
Sponsors
National Institute of Neurology, Tunisia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
prospective comparative randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Value of PVI in fluid responsiveness in neurosurgery | 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
| Measure | Time frame |
|---|---|
| Renal, metabolic and hydroelectrolytic repercussions. | up to the first 24 hours postoperatively |
| Amount of fluids administered intraoperatively | during the surgery |
| 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 |
Countries
Tunisia
Outcome results
None listed