Clinical trial NCT02793986: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Local Anesthesia
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 296
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .


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)

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 7 days after surgery
measure: Mortality in 30 days after surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Complications of cardiopulmonary system
timeFrame: 30 days after surgery
measure: Incidence of cerebrovascular accident
timeFrame: 30 days after surgery
measure: Out of bed time
timeFrame: 7 days after surgery
measure: Discharge time
timeFrame: 30 days after surgery
measure: Dosage of vasoactive agent
timeFrame: During sugary
measure: Extubation time
timeFrame: 7 days after surgery
measure: Hemodynamic index
timeFrame: intraoperative
Other outcomes:
Locations:
city: Hefei
country: China
facility: The first affiliated hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Erwei Gu, PHD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.