Effects of Two Different Goals of Fluid Management in Patients Undergoing Supratentorial Tumour Resection

NCT ID: NCT05561894

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-10-20

Brief Summary

Neurosurgical operations are characterised 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 decrease cerebral perfusion; while, fluid over-infusion might swell the brain (1-3). Thus, fluid management in these procedures complex and challenging. Evidence on the optimum protocol for intraoperative fluid management in neurosurgical patients is still lacking. Adequate intracranial volume management is considered a key factor that would overcome the tumour bulk and the surrounding vasogenic oedema facilitating surgical access . Thus, a relaxed brain is one of the targets of intraoperative fluid management during craniotomy. The slack brain would allow proper surgical retraction and consequently, reduces brain retractor ischemia. Brain relaxation scale (BRS) had shown a good correlation with intracranial pressure thus, an increasing interest was paid to BRS as a simple surrogate for intracranial pressure (4-8).

Goal-directed hemodynamic therapy (GDT) in the operating room is a term used to describe the use of defined hemodynamic targets to guide intravenous fluid and inotropic therapy. Pulse pressure variation (PPV) is one of the robust dynamic indices of fluid responsiveness which is based on heart-lung interactions (9-12). GDT had been frequently investigated in the operating room in high-risk patients especially in major surgery. However, the impact of GDT on patient outcomes, especially BRS, is not well evaluated in brain surgery (12-15). In this study, we evaluated PPV-guided fluid management compared to standard fluid management in patients undergoing supratentorial mass excision. We hypothesised that in these procedures, GDT might restrict intraoperative fluid volume, improve brain relaxation, and provide stable patient hemodynamics.

Detailed Description

Anesthetic management:

Peripheral i.v line will be inserted and 2-3 mg midazolam and 2 gm magnesium are given. A pre-induction radial arterial line is inserted with the aid of infiltration of 2 ml lidocaine 2%. Invasive arterial blood pressure monitoring is started and pulse oximetry, 5-leads ECG, and NIBP are attached to the patient and mindray ipm-12 monitor is used. Anesthetic induction started with propofol 1-2 mg/kg, lidocaine 1 mg/kg, cis-atracurium 0.2 mg/kg and fentanyl 1-2 microgram/kg. Intubation is done with cuffed endotracheal tube and tidal volume and respiratory rate are set to achieve end-tidal Co2 of 30-28 mmHg. Esophageal temperature probe and urinary catheter are put in place. Patients then will receive maintenance of anesthesia with isoflurane < 1 MAC, propofol 10-60 microgram/kg/min, dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour and cis-atracurium 2-3 microgram/kg/minute. Patients will receive mannitol 20% 0.5-1 gm/kg and dexamethasone 8mg and paracetamol 1gm near the end of surgery. Patients will receive their fasting requirements of normal saline in the first 3 hours of surgery. Maintenance fluid used will be ringer acetate and will be given according to pulse pressure variation index (PPVI) that is derived from pulse contour analysis of invasive arterial blood pressure waveform. Patients are then divided into two groups of two different targets of PPVI. Group A will be given ringer acetate when PPVI is > 12% and group B will be given ringer acetate when PPVI is > 16%.

If hypotension occurred without change in PPVI targets, it will be treated with 10 mg ephedrine. Arterial blood gas samples will be collected at induction and at the end of surgery. After removal of cranial fixation pins, anesthesia is discontinued and reversal of muscle relaxant is done with atropine 0.5 mg and neostigmine 0.05 mg/kg then extubation is done and patient is transferred to the ICU.

Conditions

Supratentorial Brain Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

A (control)

Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation index guided fluid therapy): PPVI will be measured using invasive blood pressure monitor. Ringer acetate solution will be administrated whenever PPV is higher than 12%.

Group Type: PLACEBO_COMPARATOR

pulse pressure variation index guided fluid therapy

Intervention Type: OTHER

maintainence intraoperative fluid therapy (ringer's acetate) will be given guided by either two goals of pulse pressure variation index, either \>12% or \>16%

B

Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation index guided fluid therapy): PPVI will be measured using invasive blood pressure monitor. Ringer acetate solution will be administrated whenever PPV is higher than 16%.

Group Type: ACTIVE_COMPARATOR

pulse pressure variation index guided fluid therapy

Intervention Type: OTHER

maintainence intraoperative fluid therapy (ringer's acetate) will be given guided by either two goals of pulse pressure variation index, either \>12% or \>16%

Interventions

pulse pressure variation index guided fluid therapy

maintainence intraoperative fluid therapy (ringer's acetate) will be given guided by either two goals of pulse pressure variation index, either \>12% or \>16%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

ASA 1,2 patients undergoing supratentorial tumour resection Age > 18 years Supine position

Exclusion Criteria

• ASA 3,4 patients and patients with GCS < 13
• Any other position rather than supine position
• AF or any significant arrhythmia
• Severe bradycardia that leads to low HR/RR ratio
• Severe tricuspid regurgitation or severe right ventricular dysfunction
• Patients with severe restrictive lung pathology and needing low tidal volumes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ibraheem Abdelmageed

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Assiut university

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Facility Contacts

Ibraheem Abdelmageed

Role: primary

dr.ibraheemembaby@gmail.com

+201142429670

Other Identifiers

master 1

Identifier Type: -

Identifier Source: org_study_id