drugset / Trial / NCT07479719
Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio
RandomizedParallel-groupTriple-blindPrevention
Summary
The impact of anesthesia depths on early postoperative neurocognitive complications after total intravenous anesthesia (TIVA) remains controversial. In some studies investigating TIVA, anesthesiologists mainly achieve the target depth of anesthesia by adjusting the dose of propofol, whereas the doses of opioids remains comparable between different anesthetic depth groups, possibly resulting inadequate analgesia. This study is aimed to investigate the impact of different anesthesia depths maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio on the incidence of early postoperative neurocognitive complications in older patients undergoing noncardiac surgery.
Timeline
- Start
- 2026-04
- Primary completion
- 2027-01
- Completion
- 2027-01
Publications
- Background Choi BM, Lee JS, Kim KM, Bang JY, Lee EK, Noh GJ. Frequency and characteristics of patients with bispectral index values of 60 or higher during the induction and maintenance of general anesthesia with remimazolam. Sci Rep. 2023 Jun 20;13(1):9992. doi: 10.1038/s41598-023-37150-9.
- Background Brice DD, Hetherington RR, Utting JE. A simple study of awareness and dreaming during anaesthesia. Br J Anaesth. 1970 Jun;42(6):535-42. doi: 10.1093/bja/42.6.535. No abstract available.
- Background Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
- Background Short TG, Campbell D, Frampton C, Chan MTV, Myles PS, Corcoran TB, Sessler DI, Mills GH, Cata JP, Painter T, Byrne K, Han R, Chu MHM, McAllister DJ, Leslie K; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Balanced Anaesthesia Study Group. Anaesthetic depth and complications after major surgery: an international, randomised controlled trial. Lancet. 2019 Nov 23;394(10212):1907-1914. doi: 10.1016/S0140-6736(19)32315-3. Epub 2019 Oct 20.
- Background Kusleikiene S, Ziv G, Vints WAJ, Krasinske E, Sarkinaite M, Qipo O, Bautmans I, Himmelreich U, Masiulis N, Cesnaitiene VJ, Levin O. Cognitive gains and cortical thickness changes after 12 weeks of resistance training in older adults with low and high risk of mild cognitive impairment: Findings from a randomized controlled trial. Brain Res Bull. 2025 Mar;222:111249. doi: 10.1016/j.brainresbull.2025.111249. Epub 2025 Feb 13.
- Background Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
- Background Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.
- Background Quan C, Chen J, Luo Y, Zhou L, He X, Liao Y, Chou J, Guo Q, Chen AF, Wen O. BIS-guided deep anesthesia decreases short-term postoperative cognitive dysfunction and peripheral inflammation in elderly patients undergoing abdominal surgery. Brain Behav. 2019 Apr;9(4):e01238. doi: 10.1002/brb3.1238. Epub 2019 Feb 27.
- Background Khaled M, Sabac D, Fuda M, Koubaesh C, Gallab J, Qu M, Lo Bianco G, Shanthanna H, Paul J, Thabane L, Marcucci M. Postoperative pain and neurocognitive outcomes after noncardiac surgery: a systematic review and dose-response meta-analysis. Br J Anaesth. 2025 Jan;134(1):89-101. doi: 10.1016/j.bja.2024.08.032. Epub 2024 Oct 11.
- Background Kong H, Ma DD, Ma JH, Zhang YX, Zhang H, Wang DX. Qnox index for quantification of intraoperative nociception and analgesia: a prospective single-centre validation study. Br J Anaesth. 2025 Mar;134(3):736-745. doi: 10.1016/j.bja.2024.10.051. Epub 2025 Jan 23.
- Background Tawfik GA, Lu M, De La Hoz M, Crugnola W, Jin Z, Moller D. Molecular and Clinical Considerations for Anesthesia in the Aging Brain. Int J Mol Sci. 2025 Oct 22;26(21):10272. doi: 10.3390/ijms262110272.
- Background Ryu K, Song K, Kim J, Kim E, Kim SH. Comparison of the Analgesic Properties of Sevoflurane and Desflurane Using Surgical Pleth Index at Equi-Minimum Alveolar Concentration. Int J Med Sci. 2017 Aug 18;14(10):994-1001. doi: 10.7150/ijms.20291. eCollection 2017.
- Background Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
- Background Yang Y, Song C, Song C, Li C. Comparison of Bispectral Index-Guided Individualized Anesthesia with Standard General Anesthesia on Inadequate Emergence and Postoperative Delirium in Elderly Patients Undergoing Esophagectomy: A Retrospective Study at a Single Center. Med Sci Monit. 2020 Oct 1;26:e925314. doi: 10.12659/MSM.925314.
- Background An J, Fang Q, Huang C, Qian X, Fan T, Lin Y, Guo Q. Deeper total intravenous anesthesia reduced the incidence of early postoperative cognitive dysfunction after microvascular decompression for facial spasm. J Neurosurg Anesthesiol. 2011 Jan;23(1):12-7. doi: 10.1097/ANA.0b013e3181f59db4.
- Background Shi M, Long Y, Zhou Z, Huang L, Wu D, Zhang X. The Impact of Anesthetic Management Under Bispectral Index Monitoring on the Early Recovery Quality of Elderly Patients Undergoing Laparoscopic Surgery: A Blinded Randomized Controlled Trial. Clin Interv Aging. 2025 May 14;20:597-612. doi: 10.2147/CIA.S507758. eCollection 2025.
- Background Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
- Background Evered LA, Chan MTV, Han R, Chu MHM, Cheng BP, Scott DA, Pryor KO, Sessler DI, Veselis R, Frampton C, Sumner M, Ayeni A, Myles PS, Campbell D, Leslie K, Short TG. Anaesthetic depth and delirium after major surgery: a randomised clinical trial. Br J Anaesth. 2021 Nov;127(5):704-712. doi: 10.1016/j.bja.2021.07.021. Epub 2021 Aug 28.
- Background Park SK, Han DW, Chang CH, Jung H, Kang H, Song Y. Association between Intraoperative Electroencephalogram Burst Suppression and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2025 Jan 1;142(1):107-120. doi: 10.1097/ALN.0000000000005255.
- Background Swarbrick CJ, Partridge JSL. Evidence-based strategies to reduce the incidence of postoperative delirium: a narrative review. Anaesthesia. 2022 Jan;77 Suppl 1:92-101. doi: 10.1111/anae.15607.
- Background Dilmen OK, Meco BC, Evered LA, Radtke FM. Postoperative neurocognitive disorders: A clinical guide. J Clin Anesth. 2024 Feb;92:111320. doi: 10.1016/j.jclinane.2023.111320. Epub 2023 Nov 8.
- Background Hsiao CC, Lin CJ, Hasan F, Romadlon DS, Traynor V, Hulu SRK, Chiu HY. Comparative efficacy of nonpharmacological interventions for preventing postoperative delirium in hospitalized older adults: a systematic review and network meta-analysis. Age Ageing. 2025 Aug 29;54(9):afaf264. doi: 10.1093/ageing/afaf264.
- Background Aceto P, Russo A, Galletta C, Schipa C, Romano B, Luca E, Sacco E, Totaro A, Lai C, Mazza M, Federico B, Sollazzi L. Relationship between Middle Cerebral Artery Pulsatility Index and Delayed Neurocognitive Recovery in Patients undergoing Robot-Assisted Laparoscopic Prostatectomy. J Clin Med. 2023 Jan 30;12(3):1070. doi: 10.3390/jcm12031070.
- Background Kahl U, Rademacher C, Harler U, Juilfs N, Pinnschmidt HO, Beck S, Dohrmann T, Zollner C, Fischer M. Intraoperative impaired cerebrovascular autoregulation and delayed neurocognitive recovery after major oncologic surgery: a secondary analysis of pooled data. J Clin Monit Comput. 2022 Jun;36(3):765-773. doi: 10.1007/s10877-021-00706-z. Epub 2021 Apr 15.
- Background Kong H, Xu LM, Wang DX. Perioperative neurocognitive disorders: A narrative review focusing on diagnosis, prevention, and treatment. CNS Neurosci Ther. 2022 Aug;28(8):1147-1167. doi: 10.1111/cns.13873. Epub 2022 Jun 1.
- Background Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Propofol | Small molecule | — | Intravenous |
| Comparator | Remifentanil | Small molecule | — | Intravenous |
Indications
No indication recorded.