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

March 15, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or other reasons.
  2. Previous history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
  3. Traumatic brain injury or neurosurgery.
  4. 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).
  5. Planned ICU admission with endotracheal intubation after surgery.
  6. Enrolled in the other studies.
  7. Other reasons that are considered unsuitable for study participation by the responsible surgeons or investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 50.
Drug: Light anesthesia
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
Active Comparator: Deep anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 35.
Drug: Deep anesthesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On day 4 or before hospital discharge after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
On days 1 and 3 after surgery
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.
On day 30 after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery
Time Frame: Up to 30 days after surgery.
Length of hospital stay after surgery
Up to 30 days after surgery.
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).
During the first 3 days after surgery
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).
During the first 3 nights after surgery
Percentage of ICU admission after surgery
Time Frame: Up to 24 hours after surgery.
Percentage of patients required ICU admission after surgery
Up to 24 hours after surgery.
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.
Up to 30 days after surgery
All-caused 30-day mortality
Time Frame: Up to 30 days after surgery
All-cause mortality with in 30 days after surgery.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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