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Propofol and Dexmedetomidine on Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03600727
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Anhui Medical University

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.

Condition or disease Intervention/treatment Phase
Inflammation Postoperative Delirium Anesthesia Drug: Propofol Drug: Dexmedetomidine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients receiving total hip and knee arthroplasty will be intraoperative sedated by propofol or dexmedetomidine.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes Assessor will be blinded to this study.
Primary Purpose: Supportive Care
Official Title: Intraoperative Propofol and Dexmedetomidine on Peripheral Inflammation Induced by Hip or Knee Arthroplasty.
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Propofol group
Patients in this arm will be sedated by propofol.
Drug: Propofol
Propofol will be used to offer intraoperative sedation for patients in Propofol group.

Experimental: Dexmedetomidine group
Patients in this arm will be sedated by dexmedetomidine.
Drug: Dexmedetomidine
Dexmedetomidine will be used to offer intraoperative sedation for patients in Dexmedetomidine group.




Primary Outcome Measures :
  1. change of the concentration of IL-6 [ Time Frame: Preoperative and end of surgery ]
    Change of the concentration of plasma IL-6 from baseline to the end surgery


Secondary Outcome Measures :
  1. Postoperative delirium [ Time Frame: Postoperative (1-3 days after surgery) ]
    The incidence of postoperative delirium

  2. Postoperative cognitive dysfunction [ Time Frame: Postoperative (7 and 30 days after surgery) ]
    The incidence of postoperative cognitive dysfunction

  3. change of the concentration of TNF-α [ Time Frame: Preoperative and end of surgery ]
    Change of the concentration of plasma TNF-α from baseline to the end surgery



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600727


Contacts
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Contact: Bin Mei, Ph.D +8613505603810 mb85doc@yeah.net
Contact: Xuesheng Liu, Ph.D +8655162922057 liuxuesheng@ahmu.edu.cn

Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
Investigators
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Study Chair: Zhaozhao Liang, Ph.D The First Affiliated Hospital of Anhui Medical University

Publications of Results:
Other Publications:
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Responsible Party: The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT03600727    
Other Study ID Numbers: PJ2017-06-08
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We don't want to open individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Inflammation
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action