Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT04992572
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Lumbar Spinal Stenosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Propofol Injection — DRUG
    25mg Propofol administered by injection
  • Lidocaine Hydrochloride, Injectable — DRUG
    Licocaine administered locally via injection.

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in Oswestry Disability Index (ODI) score [ Time Frame: Basline through year 2 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Outpatient Surgery Center/Stanford Spine ClinicRedwood CityCalifornia94063
Sarah Miller, MS
[email protected]
650-725-7984
Stanford Outpatient surgery centerRedwood CityCalifornia94608
Susmita Chatterjee, MS/CCRP
[email protected]
6504979271
Agnes Ith, MD
[email protected]
6504979271
Todd F Alamin, MD (PRINCIPAL_INVESTIGATOR)

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