A Phase 4 interventional study of Alprazolam and Midazolam in Cataract Surgery, Sedation and Cognition Function, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
256 studies on the registry are indexed under Patient Satisfaction; 127 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 196 interventional studies indexed under Patient Satisfaction.
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Exclusion Criteria:
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.
Drug: Alprazolam
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.
Drug: Midazolam
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.
Also known as: Xanax
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.
Also known as: Versed
Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS)
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.
Time frame: Before surgery; immediately after surgery; post-operative day 1; post-operative day 7
Participant satisfaction with sedation experience using the Iowa Satisfaction with Anesthesia Scale (ISAS)
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
Time frame: Immediately after surgery; post-operative day 1; post-operative day 7
Surgeon Satisfaction with Intraoperative Conditions
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
Time frame: Immediately after surgery
Feasibility of Recruitment
Proportion of eligible participants who agree to participate in the trial
Time frame: Throughout enrollment period
Participant Retention After Intervention
Proportion of enrolled participants who complete all postoperative follow-up assessments
Time frame: Up to 7 days post-surgery
Adherence to Sedation Intervention
Proportion of participants who receive their assigned intervention without protocol deviation (defined as receiving the intended oral or IV sedative)
Time frame: Day of surgery
Intervention Fidelity
Proportion of cases where study procedures were delivered as intended, including timing of medication administration and adherence to blinding protocol
Time frame: Day of surgery
Intraoperative Events
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.
Time frame: During surgery
Incidence of Postoperative Anesthesia-Related Complications
Incidence of postoperative anesthesia-related adverse events recorded descriptively, including delirium, nausea, vomiting, dizziness, falls, and unplanned healthcare utilization within 7 days after surgery.
Time frame: Up to 7 days after surgery
Quality of Recovery Post-Surgery (non-cognitive domains)
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.
Time frame: Post-operative days 1 and 7
Plan to share: No — This is a small single-center pilot study; therefore, investigators do not plan to make individual participant data available to other researchers.
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University of California, San Francisco