NCT04992572EARLY_PHASE1Recruiting

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Stanford University

Start Date

12/1/2021

Completion Date

12/31/2028

Summary

Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

Detailed Description

100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC. Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group. Group 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing. Group 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed

Eligibility Criteria

Age Range: 40 years to 95 years

Inclusion Criteria: Patients with lumbar stenosis to be decompressed over 1-3 segments * Ages 40-95 * Appropriate for general anesthesia Exclusion Criteria: * Planned significant nerve root retraction * Previous fusion operation * Unable to comply with follow up * Patients with daily morphine equivalents or more 100mg * Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components. * Patients with allergies to eggs, egg products, soybeans or soy products.

Interventions

DRUG

Propofol Injection

DRUG

Lidocaine Hydrochloride, Injectable

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Conditions

Lumbar Spinal Stenosis

Locations

Outpatient Surgery Center/Stanford Spine Clinic

Redwood City, California 94063

United States

Stanford Outpatient surgery center

Redwood City, California 94608

United States