Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

Study Overview
=================
Brief Summary
-----------------
Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD. Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.

Official Title
-----------------
The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty

Conditions
-----------------
Femoral Neck Fractures, Postoperative Complications, Inflammatory Response, Postoperative Delirium, Postoperative Cognitive Dysfunction

Intervention / Treatment
-----------------
* Procedure: hip arthroplasty
* Drug: Total Intravenous Anesthesia and Peripheral nerve blocks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age > 75years old Patients with femoral neck fractures Undergoing hip hemi-arthroplasty surgery American Society of Anesthesiologists (ASA) physical status II-IV MoCA being more than 23 Exclusion Criteria Patient refusal to participate in the study Patient refusal or failure of regional block allergic to local anesthetics or general anesthetics history of opioid dependence contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities) current severe psychiatric disease or alcoholism or drug dependence severe visual or auditory disorder

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Dexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes. | Procedure: hip arthroplasty<br>* Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.<br>Drug: Total Intravenous Anesthesia and Peripheral nerve blocks<br>* Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol<br>|
| Placebo Comparator: Saline<br>Participants in con group receive placebo(saline) as the same dose at the same time as dex group. | Procedure: hip arthroplasty<br>* Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.<br>Drug: Total Intravenous Anesthesia and Peripheral nerve blocks<br>* Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative cognitive dysfunction(POCD) | POCD is assessed by Montreal Cognitive Assessment(MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration,executive functions, memory, language,visuoconstructional skills, conceptual thinking,calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery | The postoperative recovery is assessed by the Post-operative Quality Recovery Scale (PQRS),which is a research tool designed to measure postoperative quality of recovery in multiple domains and over multiple time periods. Recovery domains include physiological, emotive (depression and anxiety), nociceptive (pain and nausea), cognitive, activities of daily living (ADL), and overall patient perspective (including satisfaction). | 7days | 
| Postoperative Delirium(PD) | The postoperative Delirium is assessed by the Confusion Assessment Method (CAM) | 72 hours |