140 Participants NeededMy employer runs this trial

Monitored Anesthesia Care for Hip Fracture

(MAC-STILA Trial)

Recruiting at 4 trial locations
SA
Overseen ByShifa Ahmed
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to establish preliminary efficacy of Monitored Anesthesia Care and Soft Tissue Infiltration with Local Anesthesia (MAC-STILA) on severity of post operative delirium and secondary outcomes in patients with and without cognitive impairment.

Who Is on the Research Team?

SK

Sanjit Konda, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with hip fractures, including intertrochanteric fractures, who are having surgery. People with certain medical conditions or other reasons that make anesthesia unsafe may not be able to join.

Inclusion Criteria

I am 65 or older and having surgery for a hip fracture.
My fracture was fixed with screws or a hip nail device.

Exclusion Criteria

I have a fracture near a joint replacement or implant.
Patients with severe dementia defined as pre-operative MMSE score less than 15
Patients at risk for malignant hyperthermia including history of malignant hyperthermia, family history of malignant hyperthermia susceptibility, or history of rhabdomyolysis
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • General Anesthesia
  • Monitored Anesthesia Care (MAC)
  • Soft Tissue Infiltration with Local Anesthetic (STILA)

Trial Overview

The study compares two ways of giving anesthesia during hip fracture surgery: monitored anesthesia care combined with local numbing injections (MAC-STILA) versus standard general anesthesia. The main focus is on how these methods affect confusion after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MAC-STILAExperimental Treatment2 Interventions
Group II: General AnesthesiaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+