ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 150 of 432 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Neoplasms"

Vasopressor Effects in Anesthetized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02713087
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors

Sponsor-investigator: Klaus Ulrik Koch M.D.

Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark

Objective:

To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with brain tumors. Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine

Method:

Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are infused intravenously under general anesthesia. MRI is performed in 20 patients before and after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS monitoring will be used in either scanner. After scanning patients are transported to the operating theatre and the craniotomy is performed. After removal of the bone flap subdural ICP is measured and recorded.

MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured.

Data from the proposed studies will add substantial new knowledge to the investigators current understanding of the effects of vasopressors on cerebral circulation. This information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the choice of the optimal method to manage cerebral perfusion pressure during craniotomy for brain tumor.


Condition or disease Intervention/treatment Phase
Brain Tumor Drug: Ephedrine Drug: Phenylephrine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors
Study Start Date : September 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Active Comparator: Ephedrine Drug: Ephedrine
Infusion of Ephedrine 2mg/ml until MAP above 60 mmHg or until MAP has raised 20%

Active Comparator: Phenylephrine Drug: Phenylephrine
Infusion of Phenylephrine 0,1mg/ml until MAP above 60 mmHg or until MAP has raised 20%




Primary Outcome Measures :
  1. Capillary Transit Time Heterogeneity [ Time Frame: 4 Years ]

Secondary Outcome Measures :
  1. Cerebral Metabolic Rate of Oxygen [ Time Frame: 4 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images)
  • ASA (American Society of Anesthesiologist) status 1-3 (27)
  • Written informed consent from participating patients

Exclusion Criteria:

  • Age younger than 18 yrs. or older than 75 yrs.
  • Pregnancy or nursing (negative pregnancy blood test)
  • History of allergic reactions to phenylephrine or ephedrine
  • eGFR < 60ml/min/1.73m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713087


Contacts
Contact: Klaus Ul Koch, M.D. +45 61686674 klaukoch@rm.dk
Contact: Mads Rasmussen, M.D. Ph.D. +45 78464848 mads.rasmussen@vest.rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Jylland, Denmark, 8000
Contact: Klaus Ul Koch, M.D.    +45 61686674    klaukoch@rm.dk   
Contact: Mads Rasmussen, M.D. Ph.D.    +45 78464848    mads.rasmussen@vest.rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Leif Oestergaard, Professor University of Aarhus

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02713087     History of Changes
Other Study ID Numbers: Vasobrain01
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Phenylephrine
Oxymetazoline
Ephedrine
Vasoconstrictor Agents
Pseudoephedrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents