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Anesthetics Impact on Brain Blood Flow During Surgery
Phase 4
Recruiting
Led By Jason Chui, MD
Research Sponsored by Jason Chui
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anesthesia induction
Awards & highlights
Study Summary
This trial aims to find out how anesthetics and drugs can affect blood flow to the brain during surgery, to ensure adequate blood flow to the brain and maintain its functioning.
Who is the study for?
This trial is for adults over 18 who need general anesthesia for surgery lasting more than an hour. It's not for those with neurological conditions, substance abuse history, skin issues on the forehead, or allergies to certain anesthesia drugs.Check my eligibility
What is being tested?
The study tests how different anesthetics and blood pressure drugs affect brain blood flow and energy use during surgery. Patients are randomly assigned to receive Propofol, Phenylephrine, Sevoflurane, or Ephedrine while being monitored with a new light-based device.See study design
What are the potential side effects?
Possible side effects include changes in blood pressure and heart rate due to anesthetics like Propofol and Sevoflurane or vasopressors like Phenylephrine and Ephedrine. The monitoring device itself is non-invasive but may cause discomfort where attached.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and metabolism.
Secondary outcome measures
Effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and metabolism during induction
Trial Design
4Treatment groups
Experimental Treatment
Group I: Sevoflurane-based anesthetic maintenance with phenylephrine used as the vasopressorExperimental Treatment2 Interventions
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).
Group II: Sevoflurane-based anesthetic maintenance with ephedrine used as the vasopressorExperimental Treatment2 Interventions
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).
Group III: Propofol-based anesthetic maintenance with phenylephrine used as the vasopressorExperimental Treatment2 Interventions
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).
Group IV: Propofol-based anesthetic maintenance with ephedrine used as the vasopressorExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
2014
Completed Phase 4
~2050
Ephedrine
2016
Completed Phase 4
~26810
Sevoflurane
2016
Completed Phase 4
~1260
Propofol
2017
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
Jason ChuiLead Sponsor
Jason Chui, MDPrincipal InvestigatorWestern University
2 Previous Clinical Trials
2,540 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What detrimental effects could arise from the concurrent use of Sevoflurane and phenylephrine as anesthetic maintenance?
"Sevoflurane-based anesthetic maintenance with phenylephrine as the vasopressor scored a 3 on our team's safety scale, confirming its approval for clinical use."
Answered by AI
Is the recruitment period for this experiment still open?
"Yes, the clinical trial website attests that this research protocol is actively seeking participants. It was first posted on October 3rd 2023 and recently modified on October 16th 2023; 80 subjects are required from one location."
Answered by AI
How many participants have enrolled in this research endeavor?
"Affirmative. The information published to clinicaltrials.gov is indicative of the fact that this medical trial, initially posted on October 3rd 2023, continues to recruit candidates. 80 individuals need to be enrolled at 1 dedicated location for the study's completion."
Answered by AI
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