Recruiting

Observational Study

Sponsor:

Jason Chui

Code:

NCT05941494

Conditions

Anesthesia

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Propofol

Sevoflurane

Ephedrine

Phenylephrine

Study Details

Brief summary:

The brain is a highly active organ that requires a large blood flow to function properly. Normally, blood flow is tightly linked to the brain's energy demands. However, during surgery, anesthesia can affect this relationship in different ways. Some types of anesthesia can decrease blood flow to the brain, while others can increase it. Anesthesiologists need to be careful to maintain adequate blood flow to the brain during surgery, especially when blood pressure drops. Drugs may be used to increase blood pressure, but some of these drugs can also affect blood flow to the brain. It is still unclear how to best maintain blood flow to the brain during surgery and how different types of anesthesia and drugs affect this process.

The study aims to assess the clinical utility of a new technique that uses light-based neuromonitoring to measure changes in cerebral blood flow and metabolism. The investigators will recruit 80 adult patients undergoing surgery under general anesthesia and randomize them into one of four groups to evaluate the effects of different anesthetic agents and vasopressors on brain hemodynamics and metabolism. The study will include patients over 18 years of age with no history of neurological conditions, substance abuse, or contraindications to cerebral oximetry devices or specific anesthetic agents. The patients will receive standard anesthesia care and be monitored with our light-based neuromonitoring system. This study aims to demonstrate the device's ability to detect changes in cerebral hemodynamic parameters related to anesthesia induction and systemic hypotension. This study will also evaluate the effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and neurovascular coupling.

Conditions

Anesthesia

Study ID

NCT05941494

Start date

Oct 3, 2023

Status verified date

Oct, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients over the age of 18 years old.
2. ASA I-IV
3. Undergoing surgery under general anesthesia at London Health Sciences Centre or St. Joseph's Healthcare that is scheduled to last longer than 1 hour.

Exclusion Criteria:

1. Had any neurological conditions such as history of stroke, TIA, neurodegenerative disease, or carotid stenosis
2. Had a history of substance abuse such as heavy cannabis users
3. Have a contraindication of applying the cerebral oximetry device (e.g., skin lesions in the forehead)
4. Have contraindications to receive specific anesthetic agents or vasopressors such as malignant hyperthermia or an allergy.
5. Unable to communicate with the research staff

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Propofol-based anesthetic maintenance with phenylephrine used as the vasopressor

Propofol-based anesthetic maintenance with phenylephrine used as the vasopressor. Patient will receive propofol as their maintenance agent during surgery. The typical dose is 150-200 mg/kg/min. Patient will receive phenylephrine infusion as the primary vasopressor of choice. The typical dose of phenylephrine infusion is 10-40 mcg/min (dilution 100 mcg/ml).

experimental: Propofol-based anesthetic maintenance with ephedrine used as the vasopressor

Propofol-based anesthetic maintenance with ephedrine used as the vasopressor. Patient will receive propofol as their maintenance agent during surgery. The typical dose is 150-200 mg/kg/min. The patient will receive ephedrine infusion as the primary vasopressor of choice. The typical dose of ephedrine infusion is 10-50 mg/hr (dilution 2 mg/ml).

experimental: Sevoflurane-based anesthetic maintenance with phenylephrine used as the vasopressor

Sevoflurane-based anesthetic maintenance with phenylephrine used as the vasopressor.

Patient's anesthesia will be maintained with 1 MAC of sevoflurane during surgery. Patient will receive phenylephrine infusion as the primary vasopressor of choice. The typical dose of phenylephrine infusion is 10-40 mcg/min (dilution 100 mcg/ml).

experimental: Sevoflurane-based anesthetic maintenance with ephedrine used as the vasopressor

Sevoflurane-based anesthetic maintenance with ephedrine used as the vasopressor. Patient's anesthesia will be maintained with 1 MAC of sevoflurane during surgery. The patient will receive ephedrine infusion as the primary vasopressor of choice. The typical dose of ephedrine infusion is 10-50 mg/hr (dilution 2 mg/ml).

Interventions

Propofol

Patient will receive propofol as their maintenance agent during surgery. The typical dose is 150-200 mg/kg/min.

Sevoflurane

Patient's anesthesia will be maintained with 1 MAC of sevoflurane during surgery.

Ephedrine

The patient will receive ephedrine infusion as the primary vasopressor of choice. The typical dose of ephedrine infusion is 10-50 mg/hr (dilution 2 mg/ml).

Phenylephrine

Patient will receive phenylephrine infusion as the primary vasopressor of choice. The typical dose of phenylephrine infusion is 10-40 mcg/min (dilution 100 mcg/ml).

Primary outcome measure

  • Effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and metabolism. [ Time Frame: Duration of surgery ]

Central Contacts and Locations

Central contacts

Jason Chui, MD

5196858500jason.chui@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Jason Chui, MD

5196858500jason.chui@lhsc.on.ca

More Information

Sponsor

Jason Chui

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Keywords

  • Anesthesia Drugs
  • Vasopressors
  • Neuromonitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jason Chui on 2023-10-18.