Anesthesia, Inflammation, Postoperative Delirium
Conditions
Brief summary
Dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. Possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. A greater number of studies indicated that propofol has negative effect on postoperative cognitive function. In this study, we planned to investigate the influence of these two different sedative drugs on peripheral inflammation induced by surgery and postoperative cognitive function of patients who will receive hip and knee arthroplasty.
Detailed description
Dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. Possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. A greater number of studies indicated that propofol has negative effect on postoperative cognitive function. In this study, patients who will receive hip and knee arthroplasty will be divided to two groups: Propofol group and Dexmedetomidine group. Spinal anesthesia will be used to meet the requirement of intraoperative analgesia. Patients in two groups will be sedated by propofol and dexmedetomidine, respectively. TNF-α and IL-6 in blood will be detected. And postoperative cognitive function of patients will be investigated. The objective of this study is to clarify the influence of these two different sedative drugs on peripheral inflammation induced by surgery, and the relationship with the change of postoperative cognitive function.
Interventions
DRUGPropofol
Propofol will be used to offer intraoperative sedation for patients in Propofol group.
DRUGDexmedetomidine
Dexmedetomidine will be used to offer intraoperative sedation for patients in Dexmedetomidine group.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes Assessor will be blinded to this study.
Intervention model description
Patients receiving total hip and knee arthroplasty will be intraoperative sedated by propofol or dexmedetomidine.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients included in this study were 65 years or older, were undergoing total hip arthroplasty, and were classified as American Society of Anesthesiologists (ASA) physical health class I-IV.
Exclusion criteria
* Contraindications to spinal anesthesia (i.e., coagulopathy, concurrent use of anticoagulants, infection at puncture site, and refusal of spinal anesthesia), patients with infectious diseases, patients with mental or language barriers, patients who had been anesthetized within the past 30 days, severe congestive heart failure (New York Heart Association, class IV) and/or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease Guidelines, stages III-IV), sick sinus syndrome, severe sinus bradycardia (\< 50 beats per min), and second or greater atrioventricular block without pacemaker. In addition, patients exhibiting cognitive impairment (i.e., a Mini-Mental State Examination (MMSE) score \< 24) and/or preoperative delirium (i.e., positive Confusion Assessment Method (CAM) result) were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of the concentration of IL-6 | Preoperative and end of surgery | Change of the concentration of plasma IL-6 from baseline to the end surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | Postoperative (1-3 days after surgery) | The incidence of postoperative delirium |
| Postoperative cognitive dysfunction | Postoperative (7 and 30 days after surgery) | The incidence of postoperative cognitive dysfunction |
| change of the concentration of TNF-α | Preoperative and end of surgery | Change of the concentration of plasma TNF-α from baseline to the end surgery |
Contacts
Primary ContactBin Mei, Ph.D
Backup ContactXuesheng Liu, Ph.D
Outcome results
None listed