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ElderlyPhase 4NCT07479719

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

A Phase 4 study testing Light anesthesia and Deep anesthesia in people with Elderly and Surgery, run by Peking University First Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Elderly, Surgery, Depth of Anesthesia
What is being tested?
Light anesthesia and Deep anesthesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Apr 2026to Jan 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD, PhD contact

010-83575138

wangdongxin@hotmail.com

Ding Ting, MD contact

dingting01@bjmu.edu.cn

China1 site
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PhD, 010-83572784, wangdongxin@hotmail.com

    Ting Ding, MD, 010-83575138, dingting01@bjmu.edu.cn

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Light anesthesia, Deep anesthesia
Keywords
Elderly, Surgery, Depth of anesthesia, Total intravenous anesthesia, Delayed neurocognitive recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Light anesthesiaDrug

    Also called Light anesthesia with propofol and remifentanil

    Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.

  • Deep anesthesiaDrug

    Also called Deep anesthesia with propofol and remifentanil

    Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.

Study groups in NCT07479719
Study groupRoleWhat they receive
Light anesthesiaExperimentalAnesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 50.
Receives: Drug: Light anesthesia
Deep anesthesiaActive comparatorAnesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 35.
Receives: Drug: Deep anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of delayed neurocognitive recovery

    Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitove function). A decrease of 1 SD or more from baseline is defined as cognitive decline.

    Measured: On day 4 or before hospital discharge after surgery.

Secondary outcomes (2)
  1. Quality of recovery after surgery

    Quality of recovery is assessed with the 15-item Quality of Recovery scale (QoR-15; scores range from 0 to 150, with higher scores indicating better quality of recovery).

    Measured: On days 1 and 3 after surgery

  2. Incidence of postoperative neurocognitive disorder

    Cognitive function is assessed with the telephone MoCA (T-MoCA; scores range from 0 to 20, with higher scores indicating better cognitove function). A decrease of 1 SD or more from baseline is defined as cognitive decline.

    Measured: On day 30 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479719
Sponsor's protocol ID
2026-0114
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37340043
  • 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.

    PubMed 5423844
  • 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.

    PubMed 18337600
  • 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.

    PubMed 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.2025.111249. Epub 2025 Feb 13.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30815998
  • 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.

    PubMed 39393998
  • 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.

    PubMed 39855933
  • 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.

    PubMed 41226311
  • 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.

    PubMed 28924371
  • 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.

    PubMed 30721296
  • 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.

    PubMed 33001868
  • 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.

    PubMed 21252704

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Light anesthesia and Deep anesthesia in people with Elderly and Surgery, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD, PhD (010-83575138, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delayed neurocognitive recovery (time frame: On day 4 or before hospital discharge after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479719, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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