Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

a study on Cataracts Anesthesia Patient Satisfaction

Summary

Eligibility
for people ages 65 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Catherine L Chen, M.D.
Headshot of Catherine L Chen
Catherine L Chen

Description

Summary

The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess patient satisfaction, the quality of recovery, and surgical outcomes as well as to evaluate the overall feasibility and acceptability of the study protocol for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.

Official Title

Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study

Details

This is a single-center, randomized, double-blinded, pilot clinical trial (n=10). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to compare differences in patient satisfaction, quality of recovery and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.

Keywords

Cataract, Bilateral Senile Cataract, Anesthesia, Patient Satisfaction, cataract surgery, oral sedation, intravenous sedation, conscious sedation, monitored anesthesia care, quality of recovery

Eligibility

You can join if…

Open to people ages 65 years and up

  1. ≥ 65 years old
  2. Capable of providing informed consent and completing the study procedures in English
  3. Able to provide consent for oneself
  4. Able to follow directions
  5. Able to climb one flight of stairs without stopping to rest
  6. Have a new diagnosis of cataract disease
  7. Plan on having cataract surgery on their eye within the next 6 months

You CAN'T join if...

  1. History of prior cataract surgery
  2. Admission to the hospital within the past 30 days
  3. Difficulty being sedated during other minor outpatient procedures or imaging studies
  4. Allergy or resistance to local anesthetic agents
  5. Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
  6. History of severe anxiety requiring routine use of benzodiazepines
  7. Severe valve disease (e.g., critical aortic stenosis)
  8. Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
  9. Untreated chest pain or angina
  10. Patients with movement disorders (e.g., Parkinson's Disease)
  11. History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
  12. Require home oxygen (O2) at rest or with exertion
  13. End-stage renal disease (ESRD) requiring dialysis
  14. Morbid obesity (BMI>35)
  15. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
  16. Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Catherine L Chen, M.D.
    Dr. Catherine L. Chen is a board-certified anesthesiologist and health services researcher with a primary research interest in optimizing the quality and value of care patients receive during the perioperative period. She holds an appointment as Associate Professor in the UCSF Department of Anesthesia & Perioperative Care and at the Philip R. Lee Institute for Health Policy Studies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06506669
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated
Contact us about this trial