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NCT Number: NCT07174128

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fluid therapy

Other

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

Primary outcomes

  1. Serum lactate level

    Time frame: 24 hours postoperatively

    Serum lactate level was measured at the end of surgery (immediately after extubation).

Secondary outcomes

  1. Brain Relaxation scale

    Time frame: Intraoperatively

    The 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.

  2. Heart rate

    Time frame: 20 minutes after fluid loading

    Heart rate was measured immediately after fluid loading and every 5 minutes for 20 minutes.

  3. Mean arterial pressure

    Time frame: 20 minutes after fluid loading

    Mean arterial pressure was measured immediately after fluid loading and every 5 minutes for 20 minutes.

  4. Length of hospital stay

    Time frame: Till discharge from the hospital (Up to 2 weeks)

    Length of hospital stay was recorded from admission till discharge from the hospital.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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