Delayed Neurocognitive Recovery, Depth of Anesthesia, Elderly, Surgery, Total Intravenous Anesthesia
Conditions
Keywords
Elderly, Surgery, Depth of anesthesia, Total intravenous anesthesia, Delayed neurocognitive recovery
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.
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.
Interventions
DRUGLight anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 50.
DRUGDeep anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio; the target BIS is 35.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed neurocognitive recovery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery after surgery | 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). |
| Incidence of postoperative neurocognitive disorder | 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. |
Countries
China
Contacts
CONTACTDong-Xin Wang, MD, PhD
CONTACTDing Ting, MD
PRINCIPAL_INVESTIGATORDong-Xin Wang
Peking University First Hospital
Outcome results
None listed