Oral vs IV Sedation for Cataract Surgery in Older Adults

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.

Timeline

Start

2025-08-12

Primary completion

2026-01-19

Completion

2026-01-19

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications