Clinical trial NCT05158998: Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery
Official title: Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium in Old Age
Anaesthetic
Keywords: delirium
spine surgery
anaesthetic
propofol
sevoflurane
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 298
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delirium after surgery
timeFrame: Between postoperative day 1 to discharge or day 7, whichever came first
Secondary outcomes:
measure: The day of postoperative delirium duration among patients who developed delirium
timeFrame: Time from first to last delirium-positive day. Between postoperative day 1 to discharge or day 7, whichever came first
measure: The day of total delirium-positive days among patients who developed delirium
timeFrame: Between postoperative day 1 to discharge or day 7, whichever came first
measure: The types of delirium in patients who developed delirium
timeFrame: Between postoperative day 1 to discharge or day 7, whichever came first
measure: The intubation time in postanesthesia care unit (PACU)
timeFrame: From the patient transfered into PACU to tracheal extubation. Within 24 hours after surgery.
measure: The length of stay in in postanesthesia care unit (PACU)
timeFrame: Within 24 hours after surgery.
measure: Incidence of postoperative shivering in PACU
timeFrame: Within 24 hours after surgery.
measure: Postoperative nausea and vomiting
timeFrame: Up to 3 days after surgery
measure: Incidence of emergence agitation(EA)
timeFrame: Emergence agitation will be assessed immediately after extubation. Within 24 hours after surgery.
measure: Intensity of pain within 3 days after surgery
timeFrame: Up to 3 days after surgery
measure: Postoperative recovery quality
timeFrame: The first day(6-8 PM) after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: The incidence of non-delirium complications within 30 days after surgery
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: First Affiliated Hospital of Shandong First Medical University,China.
name: wang yuelan, doctor
role: STUDY_DIRECTOR
References:
citation: Wang JH, Lv M, Zhang HX, Gao Y, Chen TT, Wan TT, Wang YL. Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial. Trials. 2022 Aug 30;23(1):720. doi: 10.1186/s13063-022-06687-x.