Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility of comparing oral sedation (a pill) with intravenous (IV) sedation for cataract surgery in older adults. Investigators will assess the feasibility, completeness, and distribution of data related to postoperative recovery, including thinking and memory, as well as participant satisfaction with care. Participants will be randomly assigned to receive either oral sedation with an IV placebo or IV sedation with an oral placebo before cataract surgery. Participants will complete brief surveys assessing recovery before and after surgery and will be contacted by phone after surgery to assess postoperative recovery. Results from this pilot study will inform the design of a future, fully powered trial evaluating sedation approaches for cataract surgery.
详细描述
This pilot clinical trial is designed to assess the feasibility of comparing two commonly used approaches to sedation during cataract surgery in older adults: oral sedation and intravenous (IV) sedation. Cataract surgery is a brief and commonly performed procedure that typically uses topical anesthetic eye drops, with sedation provided to promote comfort and relaxation. In the United States, IV sedation is frequently used and requires anesthesiology support and monitoring, whereas oral sedation is more commonly used in other settings because it is simpler to administer and less resource-intensive.
The primary focus of this study is to evaluate the feasibility, completeness, and distribution of data collection related to postoperative cognitive recovery using validated assessment tools. Secondary aims include descriptive assessments of participant satisfaction, surgeon satisfaction, recruitment success, participant retention, adherence to the assigned sedation intervention, intervention fidelity, intraoperative events, and postoperative anesthesia-related complications.
This pilot study will enroll 20 adults aged 65 years and older who are scheduled to undergo cataract surgery. Participants will be randomly assigned to receive either oral alprazolam with an IV placebo or a placebo pill with standard IV sedation using midazolam. All participants will receive topical ocular anesthesia and standard intraoperative monitoring by an anesthesia team. Cognitive recovery and other recovery outcomes will be assessed before surgery and during the postoperative period up to seven days after surgery. Findings from this study will be used to inform the design and implementation of a future, larger randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blinded study. Participants, care providers (including surgeons and anesthesia teams), outcome assessors, and investigators will all be blinded to group assignment. Pharmacy staff managing randomization will not be blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 65 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 without having symptoms (i.e., difficulty breathing, severe back pain, etc.)
- •History of severe anxiety requiring routine use of benzodiazepines
- •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
Oral Sedation Group
Participants in this group will receive oral sedation with alprazolam (0.5 mg) and IV placebo prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.
干预措施: Alprazolam (Drug)
IV Sedation Group
Participants in this group will receive IV sedation with midazolam (1 mg) and an oral placebo pill prior to cataract surgery. All participants will undergo standard cataract surgery with local anesthetic eye drops and continuous anesthesia monitoring. An IV line will be placed for monitoring, and anesthesia staff will be present during surgery, with the option to administer additional sedation if clinically indicated.
干预措施: Midazolam (Drug)
结局指标
主要结局
Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS)
时间窗: Before surgery; immediately after surgery; post-operative day 1; post-operative day 7
Feasibility, completeness, and distribution of cognitive recovery data will be assessed using the cognitive domain of the Postoperative Quality of Recovery Scale (PQRS), a validated questionnaire assessing recovery across multiple health domains. Feasibility outcomes include the proportion of participants with assessable PQRS cognitive data at each time point and the distribution of recovered versus not recovered classifications. Cognitive recovery is defined by meeting pre-specified criteria for return to baseline cognitive function compared to pre-surgery testing. The PQRS cognitive domain does not generate a numeric score; recovery is categorized as "recovered" or "not recovered." These outcomes are descriptive and intended to inform the feasibility of measurement in a future fully powered trial.
Proportion of participants with cognitive recovery based on the Postoperative Quality of Recovery Scale (PQRS) at multiple time points
时间窗: before surgery, immediately after surgery, post-operative day 1, post-operative day 7
Cognitive recovery will be measured using the cognitive domain of the PQRS, a validated questionnaire assessing recovery across several health domains. Recovery is defined by meeting pre-specified criteria for return to baseline cognitive function compared to pre-surgery testing
次要结局
- Participant satisfaction with sedation experience using the Iowa Satisfaction with Anesthesia Scale (ISAS)(Immediately after surgery; post-operative day 1; post-operative day 7)
- Quality of Recovery Post-Surgery (non-cognitive domains)(Post-operative days 1 and 7)
- Feasibility of Recruitment(Throughout enrollment period)
- Adherence to Sedation Intervention(Day of surgery)
- Participant satisfaction with sedation experience using the Iowa Satisfaction with Anesthesia Scale (ISAS)(immediately after surgery, post-operative day 1, post-operative day 7)
- Surgeon Satisfaction with Intraoperative Conditions(Immediately after surgery)
- Participant Retention After Intervention(Up to 7 days post-surgery)
- Intervention Fidelity(Day of surgery)
- Intraoperative Events(During surgery)
- Quality of Recovery Post-Surgery(Days 1 and 7 after surgery)
- Incidence of Postoperative Anesthesia-Related Complications(Up to 7 days after surgery)