Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study (CaTNAPS-1)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Cataract; Patient Satisfaction; Bilateral Senile Cataract; Anesthesia

Treatments: Procedure: Placebo; Procedure: Oral sedation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06506669

5K23AG072035-03 (U.S. NIH Grant/Contract)

23-40367

Details and patient eligibility

About

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.

Full description

This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ≥ 60 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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Oral sedation will be administered to patients prior to the procedure.

Treatment:

Procedure: Oral sedation

Placebo

Placebo Comparator group

Description:

An oral placebo pill will be administered to patients prior to the procedure.

Treatment:

Procedure: Placebo