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Clinical Trials/NCT03033706
NCT03033706
Completed
Not Applicable

Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study

Cairo University1 site in 1 country61 target enrollmentMarch 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumor
Sponsor
Cairo University
Enrollment
61
Locations
1
Primary Endpoint
Evaluation of brain relaxation
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Detailed Description

Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics, and prolonged operative time. The role of fluid therapy in these patients is very critical, hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased intracranial tension. All these factors make fluid management in these procedures complex and challenging. Evidence on the optimum protocol for intraoperative fluid management in neurosurgical patients is still lacking. Goal-directed therapy (GDT) in the operating room is a term used to describe the use of cardiac output or similar parameters to guide intravenous fluid and inotropic therapy. Although GDT was well reported in many procedures, its benefit in neurosurgical operations is not well studied. Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in major abdominal surgery with good performance. The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures GDT might improve brain relaxation, and patient hemodynamics intra and postoperatively.

Registry
clinicaltrials.gov
Start Date
March 25, 2017
End Date
January 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Hasanin

Lecturer of anesthesia and critical care medicine

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for supratentorial mass excision will be enrolled in the study.

Exclusion Criteria

  • Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.

Outcomes

Primary Outcomes

Evaluation of brain relaxation

Time Frame: one minute after dural puncture and one minute 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.

Secondary Outcomes

  • volume of intraoperative fluid requirements(intraoperatively)
  • arterial blood gases(one hour postoperatively)
  • serum lactate(one hour postoperatively)
  • prothrombin concentration(one hour postoperatively)
  • number of episodes of hypotension(intraoperatively)
  • Hemoglobin concentration(one hour postoperatively)
  • Urine output(intraoperatively)
  • heart rate(intraoperatively)

Study Sites (1)

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