Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033706
• Other study ID #: MD-4-2016
• Status: Completed
• Phase: N/A
• Start date: March 25, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 30, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Craniotomy

Intervention

Procedure:
• Pulse pressure variation guided fluid therapy
Pulse pressure variation obtained from invasive blood pressure waveform
• Traditional fluid therapy
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
Brain tumor excision under general anesthesia

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of brain relaxation	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.	one minute after dural puncture and one minute before dural closure
Secondary	volume of intraoperative fluid requirements	in litres	intraoperatively
Secondary	Urine output	Litres	intraoperatively
Secondary	heart rate	in beat per minute	intraoperatively
Secondary	number of episodes of hypotension	number of times where the blood pressure decreased by 25% of baseline	intraoperatively
Secondary	arterial blood gases	partial pressure of oxygen and carbon dioxide	one hour postoperatively
Secondary	serum lactate	in mmol per decilitre	one hour postoperatively
Secondary	Hemoglobin concentration	in grams per decilitre	one hour postoperatively
Secondary	prothrombin concentration	in percent	one hour postoperatively