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

NCT07479719 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-0114
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elderly; Surgery; Depth of Anesthesia; Total Intravenous Anesthesia; Delayed Neurocognitive Recovery

Keywords

Elderly; Surgery; Depth of anesthesia; Total intravenous anesthesia; Delayed neurocognitive recovery

Outcome Measures

Primary Outcomes (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.

  On day 4 or before hospital discharge after surgery.

Secondary Outcomes (2)

• Quality of recovery after surgery

  On days 1 and 3 after surgery

• Incidence of postoperative neurocognitive disorder

  On day 30 after surgery

Other Outcomes (6)

• Pain intensity within 3 days after surgery

  During the first 3 days after surgery

• Subjective sleep quality within 3 days after surgery

  During the first 3 nights after surgery

• Percentage of ICU admission after surgery

  Up to 24 hours after surgery.

Study Arms (2)

Light anesthesia

EXPERIMENTAL

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

Drug: Light anesthesia

Deep anesthesia

ACTIVE COMPARATOR

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

Drug: Deep anesthesia

Interventions

Light anesthesia DRUG

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

Also known as: Light anesthesia with propofol and remifentanil

Light anesthesia

Deep anesthesia DRUG

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

Also known as: Deep anesthesia with propofol and remifentanil

Deep anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dong-Xin Wang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

010-83575138; wangdongxin@hotmail.com

Ding Ting, MD

CONTACT

dingting01@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)