Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia

NCT03816072 | Completed

• 1 other identifier: METC 2018_230
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Circulation

Outcome Measures

Primary Outcomes (2)

• Changes in dCA after several MBP-increasing steps.

  Intraoperatively

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

  Intraoperatively

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Phenylephrine infusion; Other: Mechanical ventilation; Drug: Propofol

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Phenylephrine infusion; Other: Mechanical ventilation; Drug: Sevoflurane

Interventions

Phenylephrine infusion DRUG

Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.

Propofol; Sevoflurane

Mechanical ventilation OTHER

Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (\~0.1 Hz).

Propofol; Sevoflurane

Propofol DRUG

Propofol

Propofol

Sevoflurane DRUG

Sevoflurane

Sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Day case surgery
• Laparoscopy with CO2 insufflation
• Extreme positioning during surgery (head-down/up tilt, lateral decubitus position, prone)
• Surgery \< 60 minutes.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

• van den Dool REC, Sperna Weiland NH, Schenk J, Kho E, Veelo DP, van der Ster BJP, Immink RV. Dynamic cerebral autoregulation during step-wise increases in blood pressure during anaesthesia: A nonrandomised interventional trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):407-417. doi: 10.1097/EJA.0000000000001798. Epub 2023 Feb 6.

  PMID: 36655712 DERIVED

MeSH Terms

Interventions

Respiration, Artificial; Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Jeroen Hermanides, Dr.

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 25, 2019
• Study Start: January 7, 2019
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)