Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance

Not Applicable

Active, not recruiting

• Conditions: Posterior Fossa Tumor; Brain Tumor Adult
• Interventions: Procedure: Pulse pressure variation; Procedure: Central venous pressure

• Registration Number: NCT06595667
• Lead Sponsor: Chiang Mai University

Brief Summary

To answer the question: What are the differences in intraoperative fluid administration volumes between PPV and CVP-guided strategies during posterior fossa tumor resection in the park bench position?

Detailed Description

Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-02
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-09-20
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult patients aged 18 years and above
2. American Society of Anesthesiologists (ASA) I and II
3. Diagnosis of posterior fossa tumor requiring surgical resection in the park bench position, under general anesthesia at our hospital
4. Willing to participate in the study

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Exclusion Criteria

1. Arrhythmia
2. Significant cardiac diseases
3. Chronic obstructive airway disease
4. Elevated intra-abdominal pressure
5. Tumors prone to precipitate diabetes insipidus
6. Peripheral vascular disease
7. Pulmonary hypertension
8. Patients in sepsis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse pressure variation guidance fluid administration	Pulse pressure variation	In the PPV group, fluids will be administered to maintain the PPV below 13%. If hypotension coincided with a PPV exceeding 13%, an initial bolus of 200 ml crystalloid fluid solution will be given in10 minutes. PPV reassessment occurred within the subsequent 10 minutes. Alternatively, if hypotension occurs with a PPV measuring less than 13%, vasopressors such as ephedrine at a dose of 3-6 mg or norepinephrine at a dosage of 5-10 mcg intravenously as a bolus, or norepinephrine infusion at a rate of 0.03-0.3 mcg/kg/min, will be given to sustain mean arterial pressure above 65 mmHg.
Central venous pressure guidance fluid administration	Central venous pressure	In the CVP group, intraoperative fluid administration aimed to maintain CVP between 8-12 cmH2O while on mechanical ventilation, ensuring mean arterial pressure remains above 65 mmHg and heart rate within 20% of baseline.

Primary Outcome Measures

Name	Time	Method
Total intraoperative fluid administration volumes during surgery	during surgery	fluid and blood and blood volume transfusion during surgery

Secondary Outcome Measures

Name	Time	Method
vital signs	during the admission in neurosurgical ICU up to 3 days after surgery	blood pressure both systolic and diastolic pressure
time to extubation	48 hours after surgery at the neurosurgical intensive care unit	to be able to succesfully extubated, count time period of using ventilator

Trial Locations

Locations (1)

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand