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

NCT02793986 | Completed DMC

• 1 other identifier: PJ2015-07-12
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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 .

Conditions

Anesthesia; Local Anesthesia

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative delirium

  7 days after surgery

• Mortality in 30 days after surgery

  30 days after surgery

Secondary Outcomes (7)

• Complications of cardiopulmonary system

  30 days after surgery

• Incidence of cerebrovascular accident

  30 days after surgery

• Out of bed time

  7 days after surgery

• Discharge time

  30 days after surgery

• Dosage of vasoactive agent

  During sugary

Study Arms (2)

dexmedetomidine sedation

EXPERIMENTAL

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.

Drug: dexmedetomidine

propofol sedation

EXPERIMENTAL

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.

Drug: propofol

Interventions

propofol DRUG

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.

propofol sedation

dexmedetomidine DRUG

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.

dexmedetomidine sedation

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older and undergoing hip fracture repair

You may not qualify if:

• 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)

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (4)

• 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.

  PMID: 27936404 BACKGROUND

• 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.

  PMID: 28182690 BACKGROUND

• 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.

  PMID: 26822815 BACKGROUND

• 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.

  PMID: 27542303 BACKGROUND

MeSH Terms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Erwei Gu, PHD

  The First Affiliated Hospital of Anhui Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2016
• First Posted: June 8, 2016
• Study Start: August 1, 2015
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: June 29, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)