Clinical trial

Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients

Name

IMPACT study

Description

The optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aim to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen delivery to the brain and various other organs in anesthetized neurosurgical patients.

Trial arms

Trial start

2023-12-20

Estimated PCD

2025-12-31

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Noradrenalin

Infusion of noradrenaline during anesthesia and surgery

Arms:

Noradrenaline

Other names:

Noradrenaline

Phenylephrine

Infusion of phenylephrine during anesthesia and surgery

Arms:

Phenylephrine

Other names:

metaoxedrin

Size

Primary endpoint

Cerebral blood flow

Up to 3 hours (measured on the day of surgery prior to the surgical procedure)

Eligibility criteria

Inclusion Criteria: 1. Clinical diagnosis of supratentorial malignant or non-malignant brain tumors. Preferably 3 cm or larger( measured as the largest diameter in any plane on MRI). 2. Scheduled for elective supratentorial craniotomy. 3. Patients aged between 18 and 75 years. 4. American Society of Anesthesiologists status 1-3 Exclusion Criteria: 1. History of allergy or intolerance to one of the study medications. 2. Active treatment with monoamine oxidase inhibitors. 3. An American Society of Anesthesiologists (ASA)physical status IV-VI. 4. Pregnancy or breastfeeding. 5. Inability to provide written informed consent -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double blinded, clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

Updated at

2024-04-18

1 organization

2 products

1 indication

Organization

Product

Indication

Product