Cataract Monitored Anesthesia Care (MAC) Feasibility Pilot Study

Not Applicable

Recruiting

• Conditions: Anesthesia; Cataract; Bilateral Senile Cataract; Patient Satisfaction
• Interventions: Procedure: Placebo; Procedure: Oral sedation

• Registration Number: NCT06506669
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2024-06-12
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	An oral placebo pill will be administered to patients prior to the procedure.
Intervention	Oral sedation	Oral sedation will be administered to patients prior to the procedure.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)	30 minutes, 1 day and 7 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients meeting eligibility criteria	Through study completion, an average of 1 year	Number of patients meeting eligibility criteria divided by the total number of patients screened
Quality of recovery after surgery using the Postoperative Quality of Recovery Scale (PQRS)	30 minutes, 1 day and 7 days after surgery	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.
Incidence of sedation-related complications after surgery	30 days after surgery	The number of patients with a sedation-related complication divided by the number of patients enrolled in the study.
Proportion of patients completing all study surveys after cataract surgery	Through study completion, an average of 1 year	Number of patients completing all study surveys after cataract surgery divided by the number of patients enrolled in the study
Quality of recovery after surgery as measured by the Functional Recovery index (FRI)	1 day and 7 days after surgery	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.
Proportion of study patients who completed all required study procedures	Through study completion, an average of 1 year	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.
Quality of recovery after surgery as measured by the Quality-of-Recovery-15 Questionnaire (QoR-15)	1 day and 7 days after surgery	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States