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Not Yet RecruitingNCT07479719

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

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

Status
Not Yet Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Peking University First Hospital · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGLight anesthesiaAnesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.
DRUGDeep anesthesiaAnesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.

Timeline

Start date
2026-04-01
Primary completion
2027-01-01
Completion
2027-01-01
First posted
2026-03-18
Last updated
2026-03-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07479719. Inclusion in this directory is not an endorsement.