Propofol and Dexmedetomidine on Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammation Postoperative Delirium Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes Assessor will be blinded to this study.

Study Groups

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Propofol group

Patients in this arm will be sedated by propofol.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Dexmedetomidine group

Patients in this arm will be sedated by dexmedetomidine.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No