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

Not Applicable

Completed

• Conditions: Local Anesthesia; Anesthesia
• Interventions: Drug: propofol; Drug: dexmedetomidine

• Registration Number: NCT02793986
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-06
• Study First Submitted: 2016-06-04
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Last Update Submitted: 2017-06-28
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol sedation	propofol	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.
dexmedetomidine sedation	dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	7 days after surgery
Mortality in 30 days after surgery	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Complications of cardiopulmonary system	30 days after surgery
Incidence of cerebrovascular accident	30 days after surgery
Dosage of vasoactive agent	During sugary
Discharge time	30 days after surgery
Hemodynamic index	intraoperative
Out of bed time	7 days after surgery
Extubation time	7 days after surgery

Trial Locations

Locations (1)

The first affiliated hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China