Cataract Monitored Anesthesia Care (MAC) Feasibility Pilotundersøgelse (CaTNAPS-1)
11. juni 2026 opdateret af: University of California, San Francisco
Sammenligning af to normale tilgange til procedureel sedation til kataraktkirurgi: en prospektiv gennemførlighedspilotundersøgelse
Målet med dette kliniske pilotforsøg, der sammenligner to forskellige sedationstilgange til kataraktkirurgi, er at vurdere patienttilfredshed, kvaliteten af bedring og kirurgiske resultater samt at evaluere den overordnede gennemførlighed og acceptabilitet af undersøgelsesprotokollen med det formål at planlægge en større klinisk forsøg.
Deltagerne vil blive bedt om at svare på flere undersøgelser i løbet af undersøgelsen om deres oplevelse og vurdere resultater af interesse.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette er et enkeltcenter, randomiseret, dobbeltblindet, klinisk pilotforsøg (n=10).
Deltagere, der får første øjenoperation af grå stær, vil blive randomiseret til at modtage en oral benzodiazepin (intervention) eller en oral placebo-pille (kontrol).
Det primære mål med denne undersøgelse er at sammenligne forskelle i patienttilfredshed, kvalitet af bedring og kirurgiske resultater hos deltagere, der modtager oral sedation versus oral placebo til kataraktkirurgi.
De sekundære mål for denne undersøgelse er at vurdere succes med rekruttering, interventionstrohed, overholdelse af interventioner og deltagerfastholdelse efter interventioner.
Deltagerne vil blive bedt om at svare på adskillige undersøgelser på vigtige undersøgelsestidspunkter vedrørende deres sedationsoplevelser og vurdere resultater af interesse.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
23
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94143
- University of California, San Francisco
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- ≥ 65 år gammel
- I stand til at give informeret samtykke og gennemføre undersøgelsesprocedurerne på engelsk
- Kunne give samtykke til sig selv
- Kan følge anvisninger
- I stand til at gå op ad en trappe uden at stoppe for at hvile
- Har fået en ny diagnose af grå stær
- Planlæg at få operation for grå stær på deres øje inden for de næste 6 måneder
Ekskluderingskriterier:
- Historie om tidligere operation for grå stær
- Indlæggelse på hospitalet inden for de seneste 30 dage
- Besvær med at blive bedøvet under andre mindre ambulante procedurer eller billeddiagnostiske undersøgelser
- Allergi eller resistens over for lokalbedøvelsesmidler
- Kan ikke ligge fladt på ryggen uden at have symptomer (f.eks. åndedrætsbesvær, stærke rygsmerter osv.)
- Anamnese med svær angst, der kræver rutinemæssig brug af benzodiazepiner
- Alvorlig klapsygdom (f.eks. kritisk aortastenose)
- Hjertetilstande, der kræver en implanteret hjerteanordning såsom en pacemaker, defibrillator eller venstre ventrikulær hjælpeanordning (til arytmi, kongestiv hjertesvigt osv.)
- Ubehandlet brystsmerter eller angina
- Patienter med bevægelsesforstyrrelser (fx Parkinsons sygdom)
- Anamnese med cerebral vaskulær ulykke (CVA), forbigående iskæmisk anfald (TIA) eller anfald
- Kræv hjemmeilt (O2) i hvile eller ved anstrengelse
- End-stage renal disease (ESRD), der kræver dialyse
- Sygelig fedme (BMI>35)
- Patient, der gennemgår kataraktoperation i kombination med enhver anden oftalmologisk procedure
- Patient, der har behov for generel anæstesi under operation for grå stær på grund af de underliggende karakteristika ved den eksisterende grå stær og/eller forventet kompleksitet af den planlagte procedure
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
Oral sedation vil blive givet til patienter før proceduren.
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Oral medicin mod anxiolyse indgivet i præoperative omgivelser
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Placebo komparator: Placebo
En oral placebo-pille vil blive givet til patienterne forud for proceduren.
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En placebo-pille uden aktive ingredienser indgivet i præoperativ indstilling
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With High Satisfaction (ISAS Score ≥ 2)
Tidsramme: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Meeting Eligibility Criteria at Screening
Tidsramme: At screening (prior to enrollment)
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Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility
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At screening (prior to enrollment)
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Number of Participants Completing All Study Surveys at Each Timepoint
Tidsramme: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm
|
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
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Number of Participants Who Completed All Required Study Procedures
Tidsramme: From enrollment through final study follow-up (POD7)
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Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) |
From enrollment through final study follow-up (POD7)
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Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
Tidsramme: From enrollment through 30 days after surgery
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Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study
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From enrollment through 30 days after surgery
|
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Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
Tidsramme: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
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Quality of Recovery-15 (QoR-15) Total Score After Surgery
Tidsramme: 1 day and 7 days after surgery
|
The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence.
Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150.
Higher scores indicate better recovery.
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1 day and 7 days after surgery
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Functional Recovery Index (FRI) Total Score After Surgery
Tidsramme: 1 day and 7 days after surgery
|
The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living.
Each item is scored and summed to produce a total score ranging from 0 to 100.
Lower scores indicate better functional recovery.
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1 day and 7 days after surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Catherine L Chen, M.D., University of California, San Francisco
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
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- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
- Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Developed in collaboration with the American College of Surgeons, American Society of Anesthesiologists, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists, and Society of Vascular Medicine Endorsed by the Society of Hospital Medicine. J Nucl Cardiol. 2015 Feb;22(1):162-215. doi: 10.1007/s12350-014-0025-z. No abstract available.
- Partridge JS, Harari D, Dhesi JK. Frailty in the older surgical patient: a review. Age Ageing. 2012 Mar;41(2):142-7. doi: 10.1093/ageing/afr182.
- Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.
- Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.
- 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.
- Glisson C, Landsverk J, Schoenwald S, Kelleher K, Hoagwood KE, Mayberg S, Green P; Research Network on Youth Mental Health. Assessing the organizational social context (OSC) of mental health services: implications for research and practice. Adm Policy Ment Health. 2008 Mar;35(1-2):98-113. doi: 10.1007/s10488-007-0148-5. Epub 2007 Dec 18.
- 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.
- McIsaac DI, MacDonald DB, Aucoin SD. Frailty for Perioperative Clinicians: A Narrative Review. Anesth Analg. 2020 Jun;130(6):1450-1460. doi: 10.1213/ANE.0000000000004602.
- Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372.
- Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
- Norregaard, J. C. Results from the International Cataract Surgery Outcomes Study. Acta Ophthalmologica Scandinavica 85, 5-32, doi:10.1111/j.1600-0420.2007.00937.x (2007).
- Kent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).
- Andrews, M. Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery, <https://khn.org/news/anthem-calls-on-eye-surgeons-to-monitor-anesthesia-during-cataract-surgery/> (2018).
- Zakrzewski PA, Friel T, Fox G, Braga-Mele R. Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases. Ophthalmology. 2005 Feb;112(2):272-7. doi: 10.1016/j.ophtha.2004.08.016.
- Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. Clin Exp Ophthalmol. 2007 Aug;35(6):589. doi: 10.1111/j.1442-9071.2007.01553.x. No abstract available.
- Murray P, Adams K, Haddad P, Murray N, O'Rourke M. The routine requirement for anaesthetists in local anaesthetic cataract surgery. Clin Exp Ophthalmol. 2007 Mar;35(2):195-6. doi: 10.1111/j.1442-9071.2006.01441.x. No abstract available.
- Zakrzewski PA, Banashkevich AV, Friel T, Braga-Mele R. Monitored anesthesia care by registered respiratory therapists during cataract surgery: an update. Ophthalmology. 2010 May;117(5):897-902. doi: 10.1016/j.ophtha.2009.10.005. Epub 2010 Jan 15.
- Basta B, Gioia L, Gemma M, Dedola E, Bianchi I, Fasce F, Beretta L. Systemic adverse events during 2005 phacoemulsifications under monitored anesthesia care: a prospective evaluation. Minerva Anestesiol. 2011 Sep;77(9):877-83.
- Koolwijk J, Fick M, Selles C, Turgut G, Noordergraaf JI, Tukkers FS, Noordergraaf GJ. Outpatient cataract surgery: incident and procedural risk analysis do not support current clinical ophthalmology guidelines. Ophthalmology. 2015 Feb;122(2):281-7. doi: 10.1016/j.ophtha.2014.08.030. Epub 2014 Oct 22.
- Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD. Injectable versus topical anesthesia for cataract surgery: patient perceptions of pain and side effects. The Study of Medical Testing for Cataract Surgery study team. Ophthalmology. 2000 Nov;107(11):2054-60. doi: 10.1016/s0161-6420(00)00359-6.
- 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.
- Fukuoka H, Afshari NA. The impact of age-related cataract on measures of frailty in an aging global population. Curr Opin Ophthalmol. 2017 Jan;28(1):93-97. doi: 10.1097/ICU.0000000000000338.
- American Society of Anesthesiologists. ASA Calls on Anthem to Rescind Its New Policy on Anesthesia for Cataract Surgery, <https://www.asahq.org/advocacy-and-asapac/fda-and-washington-alerts/washington-alerts/2018/02/asa-calls-on-anthem-to-rescind-its-new-policy-on-anesthesia-for-cataract-surgery?&ct=fd2b35b6cdb74e0b126f4539b73b56360091233e85002bc197d8049fa56b7a4253b022b37557ad25186cfc15475fa96cd09811e97c66fe62b04a1ec1298f82ef> (2018).
- American Academy of Ophthalmology. Pressure on Anthem Grows; Academy Keeps Pushing for Cataract-Surgery Anesthesia Coverage, 2018).
- Hubbard RE, Story DA. Patient frailty: the elephant in the operating room. Anaesthesia. 2014 Jan;69 Suppl 1:26-34. doi: 10.1111/anae.12490.
- Kim DH, Patorno E, Pawar A, Lee H, Schneeweiss S, Glynn RJ. Measuring Frailty in Administrative Claims Data: Comparative Performance of Four Claims-Based Frailty Measures in the U.S. Medicare Data. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1120-1125. doi: 10.1093/gerona/glz224.
- Kim DH, Schneeweiss S, Glynn RJ, Lipsitz LA, Rockwood K, Avorn J. Measuring Frailty in Medicare Data: Development and Validation of a Claims-Based Frailty Index. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):980-987. doi: 10.1093/gerona/glx229.
- Hodge W, Horsley T, Albiani D, Baryla J, Belliveau M, Buhrmann R, O'Connor M, Blair J, Lowcock E. The consequences of waiting for cataract surgery: a systematic review. CMAJ. 2007 Apr 24;176(9):1285-90. doi: 10.1503/cmaj.060962.
- Iroku-Malize T, Kirsch S. Eye Conditions in Older Adults: Cataracts. FP Essent. 2016 Jun;445:17-23.
- Owsley C, McGwin G Jr, Sloane M, Wells J, Stalvey BT, Gauthreaux S. Impact of cataract surgery on motor vehicle crash involvement by older adults. JAMA. 2002 Aug 21;288(7):841-9. doi: 10.1001/jama.288.7.841.
- Hillman, L. Phaco turns 50, <https://www.eyeworld.org/phaco-turns-50> (2017).
- Eke T, Thompson JR. Serious complications of local anaesthesia for cataract surgery: a 1 year national survey in the United Kingdom. Br J Ophthalmol. 2007 Apr;91(4):470-5. doi: 10.1136/bjo.2006.106005. Epub 2006 Nov 23.
- Jefferis JM, Clarke MP, Taylor JP, Brittain KR. Challenges for the cataract surgeon treating people with dementia: a qualitative study exploring anesthetic choices. Clin Ophthalmol. 2014 Sep 26;8:1993-9. doi: 10.2147/OPTH.S69388. eCollection 2014.
- Norregaard JC, Bernth-Petersen P, Bellan L, Alonso J, Black C, Dunn E, Andersen TF, Espallargues M, Anderson GF. Intraoperative clinical practice and risk of early complications after cataract extraction in the United States, Canada, Denmark, and Spain. Ophthalmology. 1999 Jan;106(1):42-8. doi: 10.1016/s0161-6420(99)90004-0.
- Sharwood PL, Thomas D, Roberts TV. Adverse medical events associated with cataract surgery performed under topical anaesthesia. Clin Exp Ophthalmol. 2008 Dec;36(9):842-6. doi: 10.1111/j.1442-9071.2009.01924.x.
- Stein JD, Grossman DS, Mundy KM, Sugar A, Sloan FA. Severe adverse events after cataract surgery among medicare beneficiaries. Ophthalmology. 2011 Sep;118(9):1716-23. doi: 10.1016/j.ophtha.2011.02.024. Epub 2011 Jun 2.
- Rocha G, Turner C. Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring. Can J Ophthalmol. 2007 Apr;42(2):288-94.
- California Medical Association. CMA calls for investigation into Anthem restricting use of sedation during cataract surgery, <https://www.cmadocs.org/newsroom/news/view/ArticleID/21466/t/CMA-calls-for-investigation-into-Anthem-policy-restricting-use-of-sedation-during-cataract-surgery> (2018).
- Whitlock EL, Whittington RA. The Frailty Syndrome: Anesthesiologists Must Understand More and Fear Less. Anesth Analg. 2020 Jun;130(6):1445-1448. doi: 10.1213/ANE.0000000000004789. No abstract available.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. juni 2024
Primær færdiggørelse (Faktiske)
6. maj 2025
Studieafslutning (Faktiske)
29. maj 2025
Datoer for studieregistrering
Først indsendt
25. juni 2024
Først indsendt, der opfyldte QC-kriterier
11. juli 2024
Først opslået (Faktiske)
17. juli 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-40367
- 5K23AG072035-03 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Dette er et lille pilotstudie med et enkelt center, så vi planlægger ikke at gøre individuelle deltagerdata tilgængelige for andre forskere.
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