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Completed

NCT Number: NCT07154147

Oral vs IV Sedation for Cataract Surgery in Older Adults

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.

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Key information

Conditions

Cataract Surgery Behavior Cognition Function Health Behavior Older Adults Patient Satisfaction Perioperative Care Sedation Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

San Francisco, California, 94117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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

Treatment and study plan

alprazolam

Drug

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.

Other names: Xanax

midazolam

Drug

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.

Other names: Versed

Primary outcomes

  1. Feasibility and completeness of cognitive recovery assessment using the Postoperative Quality of Recovery Scale (PQRS)

    Time frame: 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 outcomes

  1. Participant satisfaction with sedation experience using the Iowa Satisfaction with Anesthesia Scale (ISAS)

    Time frame: 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

  2. Surgeon Satisfaction with Intraoperative Conditions

    Time frame: 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

  3. Feasibility of Recruitment

    Time frame: Throughout enrollment period

    Proportion of eligible participants who agree to participate in the trial

  4. Participant Retention After Intervention

    Time frame: Up to 7 days post-surgery

    Proportion of enrolled participants who complete all postoperative follow-up assessments

  5. Adherence to Sedation Intervention

    Time frame: Day of surgery

    Proportion of participants who receive their assigned intervention without protocol deviation (defined as receiving the intended oral or IV sedative)

  6. Intervention Fidelity

    Time frame: Day of surgery

    Proportion of cases where study procedures were delivered as intended, including timing of medication administration and adherence to blinding protocol

  7. Intraoperative Events

    Time frame: 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.

  8. Incidence of Postoperative Anesthesia-Related Complications

    Time frame: 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.

  9. Quality of Recovery Post-Surgery (non-cognitive domains)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

Acronym: CatNAPS-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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