Anesthesia, Bilateral Senile Cataract, Cataract, Patient Satisfaction
Conditions
Keywords
cataract surgery, oral sedation, intravenous sedation, conscious sedation, monitored anesthesia care, quality of recovery
Brief summary
The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes 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 assess the feasibility, completeness, and distribution of data in measuring 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.
Interventions
PROCEDUREOral sedation
Oral medication for anxiolysis administered in the preoperative setting
PROCEDUREPlacebo
A placebo pill with no active ingredients administered in the preoperative setting
Sponsors
University of California, San Francisco
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients, clinicians (operating room nurses, ophthalmologists, and anesthesia staff), and research staff responsible for data collection and analysis will be blinded to the treatment group in order to minimize bias and maximize the validity of results.
Intervention model description
A single-center, randomized, double-blinded, randomized pilot clinical trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Satisfaction (ISAS Score ≥ 2) | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) | The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting Eligibility Criteria at Screening | At screening (prior to enrollment) | Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility |
| Number of Participants Completing All Study Surveys at Each Timepoint | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) | Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm |
| Number of Participants Who Completed All Required Study Procedures | From enrollment through final study follow-up (POD7) | Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) |
| Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up | From enrollment through 30 days after surgery | Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study |
| Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) | The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. |
| Quality of Recovery-15 (QoR-15) Total Score After Surgery | 1 day and 7 days after surgery | The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence. Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150. Higher scores indicate better recovery. |
| Functional Recovery Index (FRI) Total Score After Surgery | 1 day and 7 days after surgery | The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living. Each item is scored and summed to produce a total score ranging from 0 to 100. Lower scores indicate better functional recovery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine L Chen, M.D.
University of California, San Francisco
Participant flow
Recruitment details
Recruitment occurred during the study period at UCSF-affiliated outpatient ophthalmology surgical sites. Eligible adults scheduled for elective cataract surgery were identified through surgical schedules and preoperative records. Study staff contacted patients by phone prior to surgery to screen eligibility, describe the study, and obtain informed consent.
Pre-assignment details
No washout or run-in procedures occurred between enrollment and assignment. After enrollment, participants completed baseline assessments and eligibility confirmation prior to day-of-surgery randomization. Participants who did not proceed to surgery as scheduled or withdrew consent before surgery were not assigned to a study arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 2 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed