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Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors

Effect of Two Cut-Off Values of Plethysmographic Variability Index to Guide Intraoperative Fluid Therapy on Serum Lactate in Patients Undergoing Excision of Supra-Tentorial Brain Tumors: A Randomized Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07174128
Enrollment
32
Registered
2025-09-15
Start date
2025-09-20
Completion date
2026-02-24
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cut-Off Value, Excision, Fluid Therapy, Intraoperative, Plethysmographic Variability Index, Serum Lactate, Supra-Tentorial Brain Tumors

Brief summary

This study aimed to compare two cut-off values of plethysmographic variability index (PVI) -guided fluid therapy in patients undergoing supra-tentorial mass excision regarding immediate postoperative serum lactate.

Detailed description

Fluid therapy in patients undergoing craniotomy is very critical; hypovolemia might decrease cerebral perfusion, while fluid overinfusion might cause brain swelling that impairs surgical removal of lesions. The plethysmographic variability index (PVI) is one of the dynamic indices of fluid responsiveness, a simple, automatic, non-invasive, and continuous method based on calculating changes in the perfusion index (PI).

Interventions

OTHERFluid Therapy

Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 14%.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age above 18 years old. * Both sexes. * Patients scheduled for supra-tentorial brain tumor excision.

Exclusion criteria

* Arrhythmias. * Pulmonary hypertension. * Impaired cardiac contractility. * Impaired liver or kidney function. * Low lung compliance. * Body mass index above 40. * Intra-operative hemodynamic instability on vasopressors or inotropes. * Peripheral arterial occlusive diseases. * Hand injuries or burns that preclude the application of the Masimo device probe.

Design outcomes

Primary

MeasureTime frameDescription
Serum lactate level24 hours postoperativelySerum lactate level was measured at the end of surgery (immediately after extubation).

Secondary

MeasureTime frameDescription
Brain Relaxation scaleIntraoperativelyThe neurosurgeon assessed the Brain Relaxation scale at three time intervals: with dural opening, after two hours, and before dural closure. A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.
Heart rate20 minutes after fluid loadingHeart rate was measured immediately after fluid loading and every 5 minutes for 20 minutes.
Mean arterial pressure20 minutes after fluid loadingMean arterial pressure was measured immediately after fluid loading and every 5 minutes for 20 minutes.
Length of hospital stayTill discharge from the hospital (Up to 2 weeks)Length of hospital stay was recorded from admission till discharge from the hospital.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026