Oral vs IV Sedation for Cataract Surgery in Older Adults

NCT07154147 | Completed Phase 4 FDA Drug

• 1 other identifier: 25-43837
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Cognition Function; Perioperative Care; Older Adults; Cataract Surgery

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• 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

• Feasibility of Recruitment

  Throughout enrollment period

• Participant Retention After Intervention

  Up to 7 days post-surgery

• Adherence to Sedation Intervention

  Day of surgery

Study Arms (2)

Oral Sedation Group

EXPERIMENTAL

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

IV Sedation Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Xanax

Oral Sedation Group

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.

Also known as: Versed

IV Sedation Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

San Francisco, California, 94117, United States

Location

Related Publications (11)

• 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

  BACKGROUND

• 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.

  PMID: 37276271 BACKGROUND

• 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.

  PMID: 36190717 BACKGROUND

• 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.

  PMID: 26405103 BACKGROUND

• 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.

  PMID: 26804760 BACKGROUND

• 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.

  PMID: 21519043 BACKGROUND

• 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.

  PMID: 15920188 BACKGROUND

• 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.

  PMID: 11581040 BACKGROUND

• 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.

  PMID: 9338678 BACKGROUND

• 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.

  PMID: 31002834 BACKGROUND

• 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.

  PMID: 25875258 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Alprazolam; Midazolam

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Catherine L Chen, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive either oral sedation with IV placebo or IV sedation with oral placebo for cataract surgery.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: August 12, 2025
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)