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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Supratentorial Brain Tumor
• Intervention / Treatment: Other: pulse pressure variation index guided fluid therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Assiut, Asyut Governorate, Egypt, 71111
      • Faculty of Medicine, Assiut University
      • Contact: Ibraheem Abdelmageed; Phone Number: +201142429670; Email: dr.ibraheemembaby@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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%.	Other: 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%
Active Comparator: 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%.	Other: 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative mean arterial blood pressure	measured by invasive arterial blood pressure through radial arterial line	before induction of anesthesia as a baseline, after induction and then every 15 minutes till the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative adverse cardiovascular outcomes	incidence of hypotension < 25% of baseline blood pressure	24 hours postoperative
intraoperative urine output	total amount of urine output at the end of surgery	at the end of surgery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2022
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): October 20, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: master 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No