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Trial Title:
Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance
NCT ID:
NCT06595667
Condition:
Posterior Fossa Tumor
Brain Tumor Adult
Conditions: Official terms:
Neoplasms
Infratentorial Neoplasms
Conditions: Keywords:
Parkbench position
posterior fossa tumor
pulse pressure variation
fluid responsiveness
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Two study groups are parallel according to the block of four randomization.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Outcome assessor received the anesthetic record form by unknown of the patient and group
allocation.
Intervention:
Intervention type:
Procedure
Intervention name:
Pulse pressure variation
Description:
Fluid administration during posterior fossa surgery in the parkbench position is guided
by the PPV value.
Arm group label:
Pulse pressure variation guidance fluid administration
Other name:
PPV
Intervention type:
Procedure
Intervention name:
Central venous pressure
Description:
Fluid administration during posterior fossa surgery in the parkbench position is guided
by the CVP value.
Arm group label:
Central venous pressure guidance fluid administration
Other name:
CVP
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chiang Mai University
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Start date:
September 2, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Chiang Mai University
Agency class:
Other
Source:
Chiang Mai University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595667
