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Cataract SurgeryPhase 4CatNAPS-2NCT07154147

Oral vs IV Sedation for Cataract Surgery in Older Adults

A Phase 4 study testing Alprazolam and Midazolam in people with Cataract Surgery and Sedation, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cataract Surgery, Sedation, Cognition Function
What is being tested?
Alprazolam and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Aug 2025to 19 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

    San Francisco, California, 94117

Other trials in United States

About this study

Official title: Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery 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.

Read the 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.

Being tested
Alprazolam, Midazolam
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
Medical subject headings
Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlprazolamDrug

    Also called Xanax

    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.

  • MidazolamDrug

    Also called Versed

    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.

Study groups in NCT07154147
Study groupRoleWhat they receive
Oral Sedation GroupExperimentalParticipants 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.
Receives: Drug: Alprazolam
IV Sedation GroupActive comparatorParticipants 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.
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before surgery; immediately after surgery; post-operative day 1; post-operative day 7

Secondary outcomes (9)

  1. 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

    Measured: Immediately after surgery; post-operative day 1; post-operative day 7

  2. 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

    Measured: Immediately after surgery

  3. Feasibility of Recruitment

    Proportion of eligible participants who agree to participate in the trial

    Measured: Throughout enrollment period

  4. Participant Retention After Intervention

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

    Measured: Up to 7 days post-surgery

  5. Adherence to Sedation Intervention

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

    Measured: Day of surgery

  6. Intervention Fidelity

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

    Measured: Day of surgery

  7. 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.

    Measured: During surgery

  8. 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.

    Measured: Up to 7 days after surgery

  9. 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.

    Measured: Post-operative days 1 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start12 Aug 2025
  3. Primary completion19 Jan 2026
  4. Study completion19 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to receive either oral sedation with IV placebo or IV sedation with oral placebo for cataract surgery.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154147
Sponsor's protocol ID
25-43837
Acronym
CatNAPS-2
Status last verified
Apr 2026
First submitted
26 Aug 2025
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This is a small single-center pilot study; therefore, investigators do not plan to make individual participant data available to other researchers.

Publications

  • Shah U, Wong D, Wong J. Patient satisfaction and positive patient outcomes in ambulatory anesthesia. Ambulatory Anesthesia. 2015;2:29-37 https://doi.org/10.2147/AA.S59820

  • Kugler LJ, Kapeles MJ, Durrie DS. Safety of office-based lens surgery: U.S. multicenter study. J Cataract Refract Surg. 2023 Sep 1;49(9):907-911. doi: 10.1097/j.jcrs.0000000000001231.

    PubMed 37276271

  • Perumal D, Dudley RA, Gan S, Boscardin WJ, Gill A, Gelb AW, Lee SJ, Chen CL. Anesthesia Care for Cataract Surgery in Medicare Beneficiaries. JAMA Intern Med. 2022 Oct 3;182(11):1171-80. doi: 10.1001/jamainternmed.2022.4333. Online ahead of print.

    PubMed 36190717

  • Lee RM, Thompson JR, Eke T. Severe adverse events associated with local anaesthesia in cataract surgery: 1 year national survey of practice and complications in the UK. Br J Ophthalmol. 2016 Jun;100(6):772-6. doi: 10.1136/bjophthalmol-2015-307060. Epub 2015 Sep 24.

    PubMed 26405103

  • Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.

    PubMed 26804760

  • Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25.

    PubMed 21519043

  • Fung D, Cohen M, Stewart S, Davies A. Can the Iowa Satisfaction with Anesthesia Scale be used to measure patient satisfaction with cataract care under topical local anesthesia and monitored sedation at a community hospital? Anesth Analg. 2005 Jun;100(6):1637-1643. doi: 10.1213/01.ANE.0000154203.00434.23.

    PubMed 15920188

  • Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD; Study of Medical Testing for Cataract Surgery Study Team. Adverse intraoperative medical events and their association with anesthesia management strategies in cataract surgery. Ophthalmology. 2001 Oct;108(10):1721-6. doi: 10.1016/s0161-6420(01)00704-7.

    PubMed 11581040

  • Norregaard JC, Schein OD, Bellan L, Black C, Alonso J, Bernth-Petersen P, Dunn E, Andersen TF, Espallargues M, Anderson GF. International variation in anesthesia care during cataract surgery: results from the International Cataract Surgery Outcomes Study. Arch Ophthalmol. 1997 Oct;115(10):1304-8. doi: 10.1001/archopht.1997.01100160474016.

    PubMed 9338678

  • Peeler CE, Villani CM, Fiorello MG, Lee HJ, Subramanian ML; Oral versus Intravenous Sedation Study Group. Patient Satisfaction with Oral versus Intravenous Sedation for Cataract Surgery: A Randomized Clinical Trial. Ophthalmology. 2019 Sep;126(9):1212-1218. doi: 10.1016/j.ophtha.2019.04.022. Epub 2019 Apr 16.

    PubMed 31002834

  • Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.

    PubMed 25875258

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alprazolam and Midazolam in people with Cataract Surgery and Sedation, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154147, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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