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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
20
Oral medication for anxiolysis administered in the preoperative setting
A placebo pill with no active ingredients administered in the preoperative setting
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: 30 minutes, 1 day and 7 days after surgery
Proportion of patients meeting eligibility criteria
Number of patients meeting eligibility criteria divided by the total number of patients screened
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day and 7 days after surgery
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