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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793986
• Other study ID #: PJ2015-07-12
• Status: Completed
• Phase: N/A
• First received: June 4, 2016
• Last updated: June 28, 2017
• Start date: August 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: June 2016
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Local Anesthesia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The first affiliated hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium		7 days after surgery
Primary	Mortality in 30 days after surgery		30 days after surgery
Secondary	Complications of cardiopulmonary system		30 days after surgery
Secondary	Incidence of cerebrovascular accident		30 days after surgery
Secondary	Out of bed time		7 days after surgery
Secondary	Discharge time		30 days after surgery
Secondary	Dosage of vasoactive agent		During sugary
Secondary	Extubation time		7 days after surgery
Secondary	Hemodynamic index		intraoperative