Propofol and Dexmedetomidine on Inflammation

Anesthesia Clinical Trial

Official title:

Intraoperative Propofol and Dexmedetomidine on Peripheral Inflammation Induced by Hip or Knee Arthroplasty.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03600727
• Other study ID #: PJ2017-06-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: Bin Mei, Ph.D
• Phone: +8613505603810
• Email: mb85doc[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Inflammation
• Postoperative Delirium

Intervention

Drug:
• Propofol
Propofol will be used to offer intraoperative sedation for patients in Propofol group.
• Dexmedetomidine
Dexmedetomidine will be used to offer intraoperative sedation for patients in Dexmedetomidine group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

References & Publications (2)

Memis D, Hekimoglu S, Vatan I, Yandim T, Yüksel M, Süt 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. — View 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;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the concentration of IL-6	Change of the concentration of plasma IL-6 from baseline to the end surgery	Preoperative and end of surgery
Secondary	Postoperative delirium	The incidence of postoperative delirium	Postoperative (1-3 days after surgery)
Secondary	Postoperative cognitive dysfunction	The incidence of postoperative cognitive dysfunction	Postoperative (7 and 30 days after surgery)
Secondary	change of the concentration of TNF-a	Change of the concentration of plasma TNF-a from baseline to the end surgery	Preoperative and end of surgery