Clinical trial NCT06506669: Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
Official title: Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Bilateral Senile Cataract
Anesthesia
Patient Satisfaction
Keywords: cataract surgery
oral sedation
intravenous sedation
conscious sedation
monitored anesthesia care
quality of recovery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2024-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized, double-blinded, randomized pilot clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)
timeFrame: 30 minutes, 1 day and 7 days after surgery
Secondary outcomes:
measure: Proportion of patients meeting eligibility criteria
timeFrame: Through study completion, an average of 1 year
measure: Proportion of patients completing all study surveys after cataract surgery
timeFrame: Through study completion, an average of 1 year
measure: Proportion of study patients who completed all required study procedures
timeFrame: Through study completion, an average of 1 year
measure: Incidence of sedation-related complications after surgery
timeFrame: 30 days after surgery
measure: Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS)
timeFrame: 30 minutes, 1 day and 7 days after surgery
measure: Quality of recovery after surgery as measured by the Quality-of-Recovery-15 Questionnaire (QoR-15)
timeFrame: 1 day and 7 days after surgery
measure: Quality of recovery after surgery as measured by the Functional Recovery index (FRI)
timeFrame: 1 day and 7 days after surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Catherine L Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
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