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Clinical Trial NCT07479719 for Elderly, Surgery, Depth of Anesthesia, Total Intravenous Anesthesia, Delayed Neurocognitive Recovery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio Phase 4 200

Not yet recruiting
Clinical Trial NCT07479719 is designed to study Prevention for Elderly, Surgery, Depth of Anesthesia, Total Intravenous Anesthesia, Delayed Neurocognitive Recovery. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 200 participants. Led by Peking University First Hospital, this study is expected to complete by 1 January 2027. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
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...Show More
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 monitori...Show More
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

Conditions
ElderlySurgeryDepth of AnesthesiaTotal Intravenous AnesthesiaDelayed Neurocognitive Recovery
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2026-0114
NCT ID Number
NCT07479719
Start Date (Actual)
2026-04
Last Update Posted
2026-03-18
Completion Date (Estimated)
2027-01
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Elderly
Surgery
Depth of anesthesia
Total intravenous anesthesia
Delayed neurocognitive recovery
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLight anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 50.
Light anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.
Active ComparatorDeep anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 35.
Deep anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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).
On days 1 and 3 after surgery
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.
On day 30 after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
  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.

  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.
Peking University First Hospital logoPeking University First Hospital
Study Responsible Party
Dong-Xin Wang, Principal Investigator, Chief Physician, Professor, Peking University First Hospital
Study Central Contact
Contact: Dong-Xin Wang, MD, PhD, 010-83575138, [email protected]
Contact: Ding Ting, MD, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Peking University First Hospital, Beijing, Beijing Municipality, 100034, China
Dong-Xin Wang, MD, PhD, Contact, 010-83572784, [email protected]
Ting Ding, MD, Contact, 010-83575138, [email protected]