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NCT Number: NCT07479719

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Light anesthesia

Drug

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

Other names: Light anesthesia with propofol and remifentanil

Deep anesthesia

Drug

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

Other names: Deep anesthesia with propofol and remifentanil

Primary outcomes

  1. Incidence of delayed neurocognitive recovery

    Time frame: On day 4 or before hospital discharge after surgery.

    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.

Secondary outcomes

  1. Quality of recovery after surgery

    Time frame: On days 1 and 3 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).

  2. Incidence of postoperative neurocognitive disorder

    Time frame: On day 30 after surgery

    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.

Other outcomes

  1. Pain intensity within 3 days after surgery

    Time frame: During the first 3 days after surgery

    Pain intensity is assessed twice daily (8:00-10:00, 18:00-20:00) with the numeric rating scale (NRS; scores range fro 0 to 10, with 0=no pain and 10=the worst pain).

  2. Subjective sleep quality within 3 days after surgery

    Time frame: During the first 3 nights after surgery

    Subjective sleep quality is assessed once daily (8:00-10:00) with the numeric rating scale (NRS; scores range fro 0 to 10, with 0=the best sleep and 10=the worst sleep).

  3. Percentage of ICU admission after surgery

    Time frame: Up to 24 hours after surgery.

    Percentage of patients required ICU admission after surgery

  4. Length of hospital stay after surgery

    Time frame: Up to 30 days after surgery.

    Length of hospital stay after surgery

  5. Incidence of postoperative complications within 30 days

    Time frame: Up to 30 days after surgery

    Postoperative complications are defined as new-onset conditions that are deemed harmful and required therateutic intervention, i.e., class II or higher on the Clavien-Dindo classification.

  6. All-caused 30-day mortality

    Time frame: Up to 30 days after surgery

    All-cause mortality with in 30 days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Ding Ting, MD

CONTACT

[email protected]

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

010-83575138

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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