Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
Who is this study for? Patients with Lumbar Spinal Stenosis
What treatments are being studied? Injection
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 95
Healthy Volunteers: f
View:
⁃ Patients with lumbar stenosis to be decompressed over 1-3 segments
• Ages 40-95
• Appropriate for general anesthesia
Locations
United States
California
Outpatient Surgery Center/Stanford Spine Clinic
RECRUITING
Redwood City
Stanford Outpatient surgery center
RECRUITING
Redwood City
Contact Information
Primary
Sarah Miller, MAS
sarahmi@stanford.edu
650-725-7984
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University