Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.
NCT ID: NCT02793986
Last Updated: 2017-06-29
Study Results
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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COMPLETED
NA
296 participants
INTERVENTIONAL
2015-08-31
2017-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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dexmedetomidine sedation
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.
dexmedetomidine
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.
propofol sedation
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.
propofol
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.
Interventions
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propofol
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.
dexmedetomidine
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
65 Years
85 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Anhui Medical University
OTHER
Responsible Party
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Principal Investigators
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Erwei Gu, PHD
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Anhui Medical University
Locations
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The first affiliated hospital of Anhui Medical University
Hefei, Anhui, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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PJ2015-07-12
Identifier Type: -
Identifier Source: org_study_id