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Propofol and Dexmedetomidine on Inflammation

Primary Purpose

Inflammation, Postoperative Delirium, Anesthesia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Propofol

Dexmedetomidine

About this trial

This is an interventional supportive care trial for Inflammation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Propofol group

Dexmedetomidine group

Arm Description

Patients in this arm will be sedated by propofol.

Patients in this arm will be sedated by dexmedetomidine.

Outcomes

Primary Outcome Measures

change of the concentration of IL-6

Change of the concentration of plasma IL-6 from baseline to the end surgery

Secondary Outcome Measures

Postoperative delirium

The incidence of postoperative delirium

Postoperative cognitive dysfunction

The incidence of postoperative cognitive dysfunction

change of the concentration of TNF-α

Change of the concentration of plasma TNF-α from baseline to the end surgery

Full Information

NCT ID

NCT03600727

First Posted

June 27, 2018

Last Updated

July 16, 2018

Sponsor

The First Affiliated Hospital of Anhui Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03600727

Brief Title

Propofol and Dexmedetomidine on Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Postoperative Delirium, Anesthesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

Outcomes Assessor will be blinded to this study.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propofol group

Arm Type

Experimental

Arm Description

Patients in this arm will be sedated by propofol.

Arm Title

Dexmedetomidine group

Arm Type

Experimental

Arm Description

Patients in this arm will be sedated by dexmedetomidine.

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Primary Outcome Measure Information:

Title

change of the concentration of IL-6

Description

Change of the concentration of plasma IL-6 from baseline to the end surgery

Time Frame

Preoperative and end of surgery

Secondary Outcome Measure Information:

Title

Postoperative delirium

Description

The incidence of postoperative delirium

Time Frame

Postoperative (1-3 days after surgery)

Title

Postoperative cognitive dysfunction

Description

The incidence of postoperative cognitive dysfunction

Time Frame

Postoperative (7 and 30 days after surgery)

Title

change of the concentration of TNF-α

Description

Change of the concentration of plasma TNF-α from baseline to the end surgery

Time Frame

Preoperative and end of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bin Mei, Ph.D

Phone

+8613505603810

mb85doc@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Xuesheng Liu, Ph.D

Phone

+8655162922057

liuxuesheng@ahmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaozhao Liang, Ph.D

Organizational Affiliation

The First Affiliated Hospital of Anhui Medical University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We don't want to open individual participant data (IPD) available to other researchers.

Citations:

PubMed Identifier

17363413

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.

Results Reference

background

PubMed Identifier

25788770

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.

Results Reference

result

Learn more about this trial

Propofol and Dexmedetomidine on Inflammation

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