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Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

Primary Purpose

Anesthesia, Local Anesthesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
propofol
dexmedetomidine
Sponsored by
The First Affiliated Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 65 years or older and undergoing hip fracture repair

Exclusion Criteria:

  • Patients with severe cognitive impairment (MMSE score, <15)
  • Preoperative delirium as determined by Confusion Assessment Method
  • Contraindications to local anesthesia
  • Prior hip surgery
  • Mental or language barriers that would preclude data collection
  • Severe congestive heart failure (NewYork Heart Association class IV)
  • Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)

Sites / Locations

  • The first affiliated hospital of Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dexmedetomidine sedation

propofol sedation

Arm Description

Patients received local anesthesia, in this arm, the sedation of patients was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h.

Patients received local anesthesia, in this arm, the sedation of patients was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.

Outcomes

Primary Outcome Measures

Incidence of postoperative delirium
Mortality in 30 days after surgery

Secondary Outcome Measures

Complications of cardiopulmonary system
Incidence of cerebrovascular accident
Out of bed time
Discharge time
Dosage of vasoactive agent
Extubation time
Hemodynamic index

Full Information

First Posted
June 4, 2016
Last Updated
June 28, 2017
Sponsor
The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02793986
Brief Title
Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
Official Title
Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Anhui Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine sedation
Arm Type
Experimental
Arm Description
Patients received local anesthesia, in this arm, the sedation of patients was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h.
Arm Title
propofol sedation
Arm Type
Experimental
Arm Description
Patients received local anesthesia, in this arm, the sedation of patients was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
For patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
For patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice.
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Time Frame
7 days after surgery
Title
Mortality in 30 days after surgery
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Complications of cardiopulmonary system
Time Frame
30 days after surgery
Title
Incidence of cerebrovascular accident
Time Frame
30 days after surgery
Title
Out of bed time
Time Frame
7 days after surgery
Title
Discharge time
Time Frame
30 days after surgery
Title
Dosage of vasoactive agent
Time Frame
During sugary
Title
Extubation time
Time Frame
7 days after surgery
Title
Hemodynamic index
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 65 years or older and undergoing hip fracture repair Exclusion Criteria: Patients with severe cognitive impairment (MMSE score, <15) Preoperative delirium as determined by Confusion Assessment Method Contraindications to local anesthesia Prior hip surgery Mental or language barriers that would preclude data collection Severe congestive heart failure (NewYork Heart Association class IV) Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwei Gu, PHD
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27936404
Citation
Liu X, Xie G, Zhang K, Song S, Song F, Jin Y, Fang X. Dexmedetomidine vs propofol sedation reduces delirium in patients after cardiac surgery: A meta-analysis with trial sequential analysis of randomized controlled trials. J Crit Care. 2017 Apr;38:190-196. doi: 10.1016/j.jcrc.2016.10.026. Epub 2016 Nov 11.
Results Reference
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PubMed Identifier
28182690
Citation
Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
Results Reference
background
PubMed Identifier
26822815
Citation
Orena EF, King AB, Hughes CG. The role of anesthesia in the prevention of postoperative delirium: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):669-83. Epub 2016 Jan 28.
Results Reference
background
PubMed Identifier
27542303
Citation
Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
Results Reference
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Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

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