Propofol and Dexmedetomidine on Inflammation

NCT03600727 | Unknown DMC

• 1 other identifier: PJ2017-06-08
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammation; Postoperative Delirium; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative delirium

  Postoperative (1-3 days after surgery)

• Postoperative cognitive dysfunction

  Postoperative (7 and 30 days after surgery)

• change of the concentration of TNF-α

  Preoperative and end of surgery

Study Arms (2)

Propofol group

EXPERIMENTAL

Patients in this arm will be sedated by propofol.

Drug: Propofol

Dexmedetomidine group

EXPERIMENTAL

Patients in this arm will be sedated by dexmedetomidine.

Drug: Dexmedetomidine

Interventions

Propofol DRUG

Propofol will be used to offer intraoperative sedation for patients in Propofol group.

Propofol group

Dexmedetomidine DRUG

Dexmedetomidine will be used to offer intraoperative sedation for patients in Dexmedetomidine group.

Dexmedetomidine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Related Publications (2)

• 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.

  PMID: 17363413 BACKGROUND

• 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.

  PMID: 25788770 RESULT

MeSH Terms

Conditions

Inflammation; Emergence Delirium

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhaozhao Liang, Ph.D

  The First Affiliated Hospital of Anhui Medical University

  STUDY CHAIR

Central Study Contacts

Bin Mei, Ph.D

CONTACT

+8613505603810; mb85doc@yeah.net

Xuesheng Liu, Ph.D

CONTACT

+8655162922057; liuxuesheng@ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be blinded to this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients receiving total hip and knee arthroplasty will be intraoperative sedated by propofol or dexmedetomidine.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share