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

NCT05561894 | Unknown

• 1 other identifier: master 1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• postoperative adverse cardiovascular outcomes

  24 hours postoperative

• intraoperative urine output

  at the end of surgery

Study Arms (2)

A (control)

PLACEBO COMPARATOR

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

B

ACTIVE COMPARATOR

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

Interventions

pulse pressure variation index guided fluid therapy 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%

A (control); B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: December 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: October 20, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)