Comparing Two Normal Approaches to Procedural Sedation for Cataract Surgery: A Prospective, Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With High Satisfaction (ISAS Score ≥ 2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 60 years old
- •Capable of providing informed consent and completing the study procedures in English
- •Able to provide consent for oneself
- •Able to follow directions
- •Able to climb one flight of stairs without stopping to rest
- •Have a new diagnosis of cataract disease
- •Plan on having cataract surgery on their eye within the next 6 months
排除标准
- •History of prior cataract surgery
- •Admission to the hospital within the past 30 days
- •Difficulty being sedated during other minor outpatient procedures or imaging studies
- •Allergy or resistance to local anesthetic agents
- •Cannot lay flat on your back without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
- •History of severe anxiety requiring routine use of benzodiazepines
- •Severe valve disease (e.g., critical aortic stenosis)
- •Cardiac conditions requiring an implanted cardiac device such as a pacemaker, defibrillator, or left ventricular assist device (for arrhythmia, congestive heart failure, etc.)
- •Untreated chest pain or angina
- •Patients with movement disorders (e.g., Parkinson's Disease)
- •History of Cerebral Vascular Accident (CVA), Transient Ischemic Attack (TIA), or seizures
- •Require home oxygen (O2) at rest or with exertion
- •End-stage renal disease (ESRD) requiring dialysis
- •Morbid obesity (BMI>35)
- •Patient undergoing cataract surgery in combination with any other ophthalmologic procedure
- •Patient requiring general anesthesia during cataract surgery due to the underlying characteristics of the existing cataract and/or anticipated complexity of the planned procedure
研究组 & 干预措施
Intervention
Oral sedation will be administered to patients prior to the procedure.
干预措施: Oral sedation (Procedure)
Placebo
An oral placebo pill will be administered to patients prior to the procedure.
干预措施: Placebo (Procedure)
结局指标
主要结局
Number of Participants With High Satisfaction (ISAS Score ≥ 2)
时间窗: 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.
次要结局
- Number of Participants Meeting Eligibility Criteria at Screening(At screening (prior to enrollment))
- 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 Procedures(From enrollment through final study follow-up (POD7))
- Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up(From enrollment through 30 days after surgery)
- 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))
- Quality of Recovery-15 (QoR-15) Total Score After Surgery(1 day and 7 days after surgery)
- Functional Recovery Index (FRI) Total Score After Surgery(1 day and 7 days after surgery)