Cataract Surgery, Cognition Function, Older Adults, Perioperative Care, Sedation
Conditions
Keywords
oral sedation, intravenous sedation, alprazolam, midazolam, cataract surgery, older adults, cognitive recovery, postoperative recovery, patient satisfaction, non-inferiority trial, pilot study, randomized controlled trial, anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGAlprazolam
Participants will take oral alprazolam 0.5 mg 15 to 90 minutes before surgery to promote relaxation and reduce anxiety. An IV placebo (normal saline) will be administered to maintain blinding.
DRUGMidazolam
Participants will receive IV midazolam 1 mg immediately before surgery to promote relaxation and reduce anxiety. An oral placebo pill will be used to maintain blinding.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned to receive either oral sedation with IV placebo or IV sedation with oral placebo for cataract surgery.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 65 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 without having symptoms (i.e., difficulty breathing, severe back pain, etc.) 6. History of severe anxiety requiring routine use of benzodiazepines 7. Patient undergoing cataract surgery in combination with any other ophthalmologic procedure 8. 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 |
|---|---|---|
| Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction with sedation experience using the Iowa Satisfaction with Anesthesia Scale (ISAS) | Immediately after surgery; post-operative day 1; post-operative day 7 | Participants will complete the ISAS to rate satisfaction with their anesthesia experience, including feelings of relaxation, comfort, and recall of surgery. The Iowa Satisfaction with Anesthesia Scale (ISAS) ranges from -3 to +3, with higher scores indicating greater satisfaction |
| Surgeon Satisfaction with Intraoperative Conditions | Immediately after surgery | Measured via post-surgery surgeon questionnaire assessing perceived ease of surgery, patient cooperation, and need for additional sedation. The Surgeon Intraoperative Satisfaction Questionnaire uses a 6-point Likert scale (1-6), where 1 indicates very poor surgical conditions and 6 indicates excellent surgical conditions. Higher scores indicate better intraoperative conditions |
| Feasibility of Recruitment | Throughout enrollment period | Proportion of eligible participants who agree to participate in the trial |
| Participant Retention After Intervention | Up to 7 days post-surgery | Proportion of enrolled participants who complete all postoperative follow-up assessments |
| Adherence to Sedation Intervention | Day of surgery | Proportion of participants who receive their assigned intervention without protocol deviation (defined as receiving the intended oral or IV sedative) |
| Intervention Fidelity | Day of surgery | Proportion of cases where study procedures were delivered as intended, including timing of medication administration and adherence to blinding protocol |
| Intraoperative Events | During surgery | Incidence of intraoperative events recorded descriptively, including participant complaints of pain or discomfort, anxiety or nervousness, requests for additional IV medication, undesirable patient movement, surgeon complaints regarding sedation adequacy, and conversion to general anesthesia. |
| Incidence of Postoperative Anesthesia-Related Complications | Up to 7 days after surgery | Incidence of postoperative anesthesia-related adverse events recorded descriptively, including delirium, nausea, vomiting, dizziness, falls, and unplanned healthcare utilization within 7 days after surgery. |
| Quality of Recovery Post-Surgery (non-cognitive domains) | Post-operative days 1 and 7 | Quality of recovery will be assessed descriptively using the physical comfort and emotional well-being domains of the Postoperative Quality of Recovery Scale (PQRS), excluding the cognitive domain, compared to baseline. The PQRS does not generate numeric scores; recovery is categorized as "recovered" or "not recovered," with no minimum or maximum values. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine L Chen, MD, MPH
University of California, San Francisco
Outcome results
None listed