Skip to main content
OpenTrials
Completed

NCT Number: NCT03033706

Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pulse pressure variation guided fluid therapy

Procedure

Pulse pressure variation obtained from invasive blood pressure waveform

Traditional fluid therapy

Procedure

4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.

Brain tumor excision

Procedure

Brain tumor excision under general anesthesia

Primary outcomes

  1. 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

  1. volume of intraoperative fluid requirements

    Time frame: intraoperatively

    in litres

  2. Urine output

    Time frame: intraoperatively

    Litres

  3. heart rate

    Time frame: intraoperatively

    in beat per minute

  4. number of episodes of hypotension

    Time frame: intraoperatively

    number of times where the blood pressure decreased by 25% of baseline

  5. arterial blood gases

    Time frame: one hour postoperatively

    partial pressure of oxygen and carbon dioxide

  6. serum lactate

    Time frame: one hour postoperatively

    in mmol per decilitre

  7. Hemoglobin concentration

    Time frame: one hour postoperatively

    in grams per decilitre

  8. prothrombin concentration

    Time frame: one hour postoperatively

    in percent

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Nov 23, 2018

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.

Published trials that share one or more normalized conditions with this study.