Clinical trial NCT03600727: Propofol and Dexmedetomidine on Inflammation
Official title: Intraoperative Propofol and Dexmedetomidine on Peripheral Inflammation Induced by Hip or Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Postoperative Delirium
Anesthesia
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients receiving total hip and knee arthroplasty will be intraoperative sedated by propofol or dexmedetomidine.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of the concentration of IL-6
timeFrame: Preoperative and end of surgery
Secondary outcomes:
measure: Postoperative delirium
timeFrame: Postoperative (1-3 days after surgery)
measure: Postoperative cognitive dysfunction
timeFrame: Postoperative (7 and 30 days after surgery)
measure: change of the concentration of TNF-α
timeFrame: Preoperative and end of surgery
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Zhaozhao Liang, Ph.D
role: STUDY_CHAIR
References:
citation: Memis D, Hekimoglu S, Vatan I, Yandim T, Yuksel M, Sut N. Effects of midazolam and dexmedetomidine on inflammatory responses and gastric intramucosal pH to sepsis, in critically ill patients. Br J Anaesth. 2007 Apr;98(4):550-2. doi: 10.1093/bja/aem017. No abstract available.
citation: Shoair OA, Grasso Ii MP, Lahaye LA, Daniel R, Biddle CJ, Slattum PW. Incidence and risk factors for postoperative cognitive dysfunction in older adults undergoing major noncardiac surgery: A prospective study. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):30-6. doi: 10.4103/0970-9185.150530.