Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio

Официальное название

Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio on Neurocognitive Recovery in Older Patients After Surgery: a Randomized Trial

Обзор

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.

Подробное описание

Early postoperative neurocognitive complications are associated with worse perioperative and long-term outcomes, substantially affecting patients' prognosis and recovery and imposing a significant healthcare and economic burden. Bispectral index (BIS) is an objective and quantitative monitoring parameter used to assess patients' depth of anesthesia. Maintenance of general anesthesia under the guidance of BIS monitoring has been shown to reduce the incidence of early postoperative neurocognitive complications following inhalational anesthesia or combined intravenous-inhalational anesthesia.

However, the impact of different depths of anesthesia maintenance on early postoperative neurocognitive complications after total intravenous anesthesia (TIVA) remains controversial. In some studies investigating TIVA, anesthesiologists mainly achieve the target BIS by adjusting the dosage of propofol, whereas the dosage of opioids remains comparable between different anesthetic depth groups. Based on previous studies, the investigators supposed that target-controlled infusion of propofol to remifentanil at a fixed ratio might ensure adequate intraoperative sedation and analgesia and reduce postoperative neurocognitive complications.

This study is aimed to investigate the impact of different anesthesia depths by target-controlled infusion of propofol and remifentanil at a fixed effect-site concentration ratio on the incidence of early postoperative neurocognitive complications in older patients undergoing noncardiac surgery.

Вмешательства

• Препарат Light anesthesia
  Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.
• Препарат Deep anesthesia
  Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.

Первичные конечные точки

• Incidence of delayed neurocognitive recovery [Срок оценки: On day 4 or before hospital discharge after surgery.]

Вторичные конечные точки (2)

• Quality of recovery after surgery [Срок оценки: On days 1 and 3 after surgery]
• Incidence of postoperative neurocognitive disorder [Срок оценки: On day 30 after surgery]

Критерии участия

Критерии включения

• Aged ≥ 65 years.
• Scheduled to undergo noncardiac surgery expected to last ≥ 1 hour under general anesthesia.
• Require patient-controlled intravenous analgesia after surgery.
• Provide written informed consent.

Критерии исключения

• Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or other reasons.
• Previous history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
• Traumatic brain injury or neurosurgery.
• Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR <30 ml/min/1.73 m2), or critical illness (preoperative American Society of Anesthesiologists physical status classification ≥IV).
• Planned ICU admission with endotracheal intubation after surgery.
• Enrolled in the other studies.
• Other reasons that are considered unsuitable for study participation by the responsible surgeons or investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Публикации

• 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. PMID 37340043
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• 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(10 PMID 31645286
• 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 PMID 39954817
• 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. PMID 21233500
• 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. PMID 19411668
• 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. PMID 30815998

Идентификаторы

NCT: NCT07479719 · 2026-0114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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