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Clinical Trials/NCT03816072
NCT03816072
Completed
Not Applicable

Simultaneous Quantification of Dynamic and Static Cerebral Autoregulation (CA) at Different Steady-state Mean Blood Pressures Under Anaesthesia.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country66 target enrollmentJanuary 7, 2019

Overview

Phase
Not Applicable
Intervention
Phenylephrine infusion
Conditions
Cerebrovascular Circulation
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
66
Locations
1
Primary Endpoint
Differences in dCA between sevoflurane and propofol at different steady-state MBP's.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different blood pressure levels are difficult because they are invasive and time-consuming. This type of measurement to quantify CA is generally referred to as static cerebral autoregulation (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels react to a change in blood pressure to normalize CBF. Since the introduction of transcranial Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy, which in turn correlates well with CBF changes. This method is widely used to quantify dCA. However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood pressure (MBP). It is important to compare different methods of assessing CA, because impaired CA may result in increased risk of perioperative complications such as stroke. In this study, the investigators were interested in establishing the relationship between sCA and dCA during surgery under general anesthesia. The investigators aim to compare these methods during propofol and sevoflurane anesthesia.

Registry
clinicaltrials.gov
Start Date
January 7, 2019
End Date
September 23, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Niek Sperna Weiland

MD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • ASA-I or ASA-II, willing and able to give written informed consent, scheduled for elective, non-cardiothoracic surgery under general anaesthesia and age 18 years and above.

Exclusion Criteria

  • Patient related
  • Unable/ unwilling to participate
  • ASA-III or higher
  • Age \< 18 years
  • History of: uncontrolled hypertension, diabetes, Parkinson's disease, uncontrolled cardiac arrhythmia, Pure autonomic failure (formerly called idiopathic orthostatic hypotension), Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome), Addison's disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy), known cardiomyopathy, extreme left ventricle hypertrophy or ejection fraction \< 30%, proven or suspected allergy for any of the medication used during induction of anaesthesia, malignant hyperthermia.
  • Unability to record transcranial Doppler ultrasound due to anatomical variance (\~5% of population)
  • Contra-indications for intravenous or inhalational anaesthesia.
  • Contra-indications for phenylephrine: severe hypertension, peripheral vascular illness, severe hyperthyroidism
  • Simultaneous use of MAO-inhibitors, dopaminergic or vasoconstrictor ergot alkaloids (bromocriptine, cabergoline, pergolide, ergotamine, methylergometrine, methysergide), linezolid, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, digoxin, quinidine, oxytocin.
  • Surgery related

Arms & Interventions

Propofol

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol).

Intervention: Phenylephrine infusion

Propofol

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol).

Intervention: Mechanical ventilation

Propofol

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol).

Intervention: Propofol

Sevoflurane

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane).

Intervention: Phenylephrine infusion

Sevoflurane

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane).

Intervention: Mechanical ventilation

Sevoflurane

ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane).

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Differences in dCA between sevoflurane and propofol at different steady-state MBP's.

Time Frame: Intraoperatively

Changes in dCA after several MBP-increasing steps.

Time Frame: Intraoperatively

Study Sites (1)

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