Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
NCT ID: NCT04992572
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2021-12-01
2028-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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General anesthesia
Patients under this group will be undergoing lumbar decompression surgery with general anesthesia:
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.
Propofol Injection
25mg Propofol administered by injection
Monitored Anesthetic Care (MAC)/Local
Patients under this group wil be undergoing limbar decompression surgery with Monitored Anesthetic care, (MAC)/Local.
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.
Lidocaine Hydrochloride, Injectable
Licocaine administered locally via injection.
Interventions
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Propofol Injection
25mg Propofol administered by injection
Lidocaine Hydrochloride, Injectable
Licocaine administered locally via injection.
Eligibility Criteria
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Inclusion Criteria
* Ages 40-95
* Appropriate for general anesthesia
Exclusion Criteria
* 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.
40 Years
95 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Todd Alamin
Professor
Principal Investigators
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Todd Alamin, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Outpatient Surgery Center/Stanford Spine Clinic
Redwood City, California, United States
Stanford Outpatient surgery center
Redwood City, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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61453
Identifier Type: -
Identifier Source: org_study_id
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