Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Location contact
Dong-Xin Wang, MD, PhD
CONTACT
Ting Ding, MD
CONTACT
NCT Number: NCT07479719
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
Dong-Xin Wang, MD, PhD
CONTACT
Ting Ding, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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).
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.
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).
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).
Time frame: Up to 24 hours after surgery.
Percentage of patients required ICU admission after surgery
Time frame: Up to 30 days after surgery.
Length of hospital stay after surgery
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.
Time frame: Up to 30 days after surgery
All-cause mortality with in 30 days after surgery.
Contact information is provided by the study sponsor or research team.
Ding Ting, MD
CONTACT
Dong-Xin Wang, MD, PhD
CONTACT
Peking University First Hospital
Other
Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio on Neurocognitive Recovery in Older Patients After Surgery: a Randomized Trial
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