Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery

Qianfoshan Hospital

Status and phase: Enrolling; Phase 4

Conditions: Anaesthetic; Delirium in Old Age

Treatments: Drug: sevoflurane inhalation; Drug: propofol infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05158998

QianfoshanH PSPOD

Details and patient eligibility

About

Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.

Full description

Spine surgery is the third most common surgical procedure in older patients. With the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. The pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. Among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. Meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. Given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. There are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. Therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.

Enrollment: 298 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥65 years and ≤90 years;
2. scheduled to undergo surgery for spinal, under general anaesthesia;
3. American Society of Anesthesiology (ASA) I-III;
4. agree to participate, and give signed written informed consents.

Exclusion criteria

1. family history or history of malignant hyperthermia;
2. History of propofol or sevoflurane allergy;
3. demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, <24of 30 or <20 of 30 if the patient's education year was less than 6 years or<17 if the patient is Illiterate);
4. planned postoperative intubation or transferred to ICU;
5. severe visual or auditory handicap;
6. prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, Parkinson's disease, dementia, schizophrenia, or depressive illness)
7. take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation
8. participating in other clinical studies in recent 3 months

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

298 participants in 2 patient groups

propofol group

Other group

Description:

For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Propofol infusion will be stopped at the end of surgery.

Treatment:

Drug: propofol infusion

sevoflurane group

Other group

Description:

For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery.

Treatment:

Drug: sevoflurane inhalation