Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study
NCT Number: NCT06506669
Acronym: CaTNAPS-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract|Bilateral Senile Cataract|Anesthesia|Patient Satisfaction
Interventions: PROCEDURE: Oral sedation|PROCEDURE: Placebo
Sponsor: University of California, San Francisco
Collaborators: National Institutes of Health (NIH)|National Institute on Aging (NIA)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-12
Completion Date: 2024-12
Locations: University of California, San Francisco, San Francisco, California, 94143, United States

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.

Primary Outcome Measures: Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS), The ISAS is a validated 11-question survey to find out how people feel about the sedation (i.e., monitored anesthesia care) they received during surgery that doesn't require general anesthesia. It asks about pain and overall feelings about the anesthesia care received. We will compare ISAS scores between patients who received oral sedation and patients who received placebo., 30 minutes, 1 day and 7 days after surgery
Secondary Outcome Measures: Proportion of patients meeting eligibility criteria, Number of patients meeting eligibility criteria divided by the total number of patients screened, Through study completion, an average of 1 year|Proportion of patients completing all study surveys after cataract surgery, Number of patients completing all study surveys after cataract surgery divided by the number of patients enrolled in the study, Through study completion, an average of 1 year|Proportion of study patients who completed all required study procedures, The number of study patients who completed all required study procedures (before and after surgery) divided by the number of patients enrolled in the study., Through study completion, an average of 1 year|Incidence of sedation-related complications after surgery, The number of patients with a sedation-related complication divided by the number of patients enrolled in the study., 30 days after surgery|Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS), The PQRS is a 6-question survey that assesses the quality of recovery of patients after surgery. It evaluates multiple aspects of recovery, including physiological, pain, emotional, brain function, and activities of daily living domains., 30 minutes, 1 day and 7 days after surgery|Quality of recovery after surgery as measured by the Quality-of-Recovery-15 Questionnaire (QoR-15), The QoR-15 is a survey that has 15 questions and is used to see how patients feel after surgery and helps to understand the trajectory of recovery from surgery and anesthesia. The survey includes questions about mood, including if patients are feeling anxious or depressed., 1 day and 7 days after surgery|Quality of recovery after surgery as measured by the Functional Recovery index (FRI), The FRI is a 14-question survey to check how well patients can do normal activities after surgery. It asks about things like pain, moving around, and daily activities., 1 day and 7 days after surgery