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

NCT07174128 | Completed

• 1 other identifier: MD--452-2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Serum lactate level

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

  24 hours postoperatively

Secondary Outcomes (4)

• Brain Relaxation scale

  Intraoperatively

• Heart rate

  20 minutes after fluid loading

• Mean arterial pressure

  20 minutes after fluid loading

• Length of hospital stay

  Till discharge from the hospital (Up to 2 weeks)

Study Arms (2)

Low PVI group

EXPERIMENTAL

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

Other: Fluid Therapy

High PVI gro

EXPERIMENTAL

Patients would receive the second round of fluid loading if the Plethysmographic Variability Index (PVI) was 20%.

Other: Fluid Therapy

Interventions

Fluid Therapy OTHER

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

Low PVI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Pain Management and surgical ICU, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 15, 2025
• Study Start: September 20, 2025
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)