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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and metabolism.

Secondary study objectives

Effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and metabolism during induction

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Sevoflurane

2016

Completed Phase 4

~1260

Ephedrine

2016

Completed Phase 4

~26810