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

NCT ID: NCT06595667

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2025-10-31

Brief Summary

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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

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

Conditions

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Posterior Fossa Tumor Brain Tumor Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two study groups are parallel according to the block of four randomization.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcome assessor received the anesthetic record form by unknown of the patient and group allocation.

Study Groups

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Pulse pressure variation guidance fluid administration

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.

Group Type EXPERIMENTAL

Pulse pressure variation

Intervention Type PROCEDURE

Fluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value.

Central venous pressure guidance fluid administration

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.

Group Type EXPERIMENTAL

Central venous pressure

Intervention Type PROCEDURE

Fluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value.

Interventions

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Pulse pressure variation

Fluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value.

Intervention Type PROCEDURE

Central venous pressure

Fluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value.

Intervention Type PROCEDURE

Other Intervention Names

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PPV CVP

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Pathomporn Pin on, M.D.

Associate Professor Pathomporn Pin on

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pathomporn P Pin on, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Site Status

Countries

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Thailand

References

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Pin On P, Kacha S, Saringkarinkul A, Thanakititham N. Study protocol for a randomized controlled trial comparing pulse pressure variation (PPV) and central venous pressure (CVP) guidance for fluid responsiveness assessment in neurosurgical patients undergoing posterior fossa tumor resection in park bench position. PLoS One. 2025 Jun 2;20(6):e0324590. doi: 10.1371/journal.pone.0324590. eCollection 2025.

Reference Type DERIVED
PMID: 40455866 (View on PubMed)

Other Identifiers

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Chiang Mai University

Identifier Type: OTHER

Identifier Source: secondary_id

ANE-2567-0391

Identifier Type: -

Identifier Source: org_study_id

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