NCT05158998

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

Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium in Old Age
• Anaesthetic

Interventions

Type	Name	Description
DRUG	propofol infusion	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.
DRUG	sevoflurane inhalation	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.

Timeline

• Start date: 2022-03-21
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2021-12-15
• Last updated: 2022-06-02

Locations

2 sites across 1 country: China