Clinical trial NCT06176144: Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients
Official title: Impact of Desflurane Versus Sevoflurane Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 890
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.

Detailed description: With increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. Rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. Using inhalational anesthetics is the mainstay of general anesthesia. Since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. Studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. Concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. However, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. Desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. Desflurane is increasingly used in elderly patients in clinical practice. However, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 65 years and \< 90 years;
2. Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;
3. Agree to participate, and give signed written informed consent.

Exclusion Criteria:

1. Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
2. Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
3. Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
4. Alcoholism and drug dependence;
5. Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).

Primary outcomes:
measure: postoperative delirium
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: Quality of recovery, QoR15 (Quality of Recovery 15)
timeFrame: The day before surgery and on the 7th day after surgery or discharge
measure: Subjective sleep quality (NRS) within 3 days after surgery.
timeFrame: Up to 3 days after surgery
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery
measure: Percentage of intensive care unit (ICU) admission after surgery.
timeFrame: Within 24 hours after surgery
measure: Length of stay in ICU after surgery.
timeFrame: Up to 30 days after surgery
measure: Incidence of complications within 30 days
timeFrame: Up to 30 days after surgery
measure: Intensity of pain within 3 days after surgery
timeFrame: Up to 3 days after surgery
measure: Incidence of postoperative cognitive dysfunction (POCD)
timeFrame: The day before surgery and on the 7th day after surgery or discharge
Other outcomes:
measure: Cognitive function at 30 days after surgery
timeFrame: On the 30th day after surgery
measure: TNF-α concentration
timeFrame: The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.
measure: IL-6 concentration
timeFrame: The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.
Locations:
city: Chengdu
country: China
facility: Department of Anesthesiology, West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Jing Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: