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

Primary Purpose

Supratentorial Brain Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulse pressure variation index guided fluid therapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Supratentorial Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A (control)

B

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

intraoperative mean arterial blood pressure
measured by invasive arterial blood pressure through radial arterial line

Secondary Outcome Measures

postoperative adverse cardiovascular outcomes
incidence of hypotension < 25% of baseline blood pressure
intraoperative urine output
total amount of urine output at the end of surgery

Full Information

First Posted
September 28, 2022
Last Updated
November 26, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05561894
Brief Title
Effects of Two Different Goals of Fluid Management in Patients Undergoing Supratentorial Tumour Resection
Official Title
Effects of Two Different Goals of Fluid Management in Patients Undergoing Supratentorial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (control)
Arm Type
Placebo Comparator
Arm Description
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%.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Other
Intervention Name(s)
pulse pressure variation index guided fluid therapy
Intervention Description
maintainence intraoperative fluid therapy (ringer's acetate) will be given guided by either two goals of pulse pressure variation index, either >12% or >16%
Primary Outcome Measure Information:
Title
intraoperative mean arterial blood pressure
Description
measured by invasive arterial blood pressure through radial arterial line
Time Frame
before induction of anesthesia as a baseline, after induction and then every 15 minutes till the end of surgery
Secondary Outcome Measure Information:
Title
postoperative adverse cardiovascular outcomes
Description
incidence of hypotension < 25% of baseline blood pressure
Time Frame
24 hours postoperative
Title
intraoperative urine output
Description
total amount of urine output at the end of surgery
Time Frame
at the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of medicine, Assiut university
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
71111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibraheem Abdelmageed
Phone
+201142429670
Email
dr.ibraheemembaby@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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