Clinical trial NCT01934049: Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
Official title: The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Femoral Neck Fractures
Postoperative Complications
Inflammatory Response
Postoperative Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: postoperative cognitive dysfunction(POCD)
timeFrame: 7days
Secondary outcomes:
measure: Postoperative recovery
timeFrame: 7days
measure: Postoperative Delirium(PD)
timeFrame: 72 hours
Other outcomes:
measure: postoperative complications
timeFrame: 7 days
measure: perioperative opioid consumption
timeFrame: 3 days
measure: IL-6 and C-reacting protein
timeFrame: 7 days
measure: MB isoenzyme of creatine kinase and blood sugar
timeFrame: 7 days
Locations:
city: Beijing
country: China
facility: Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
Study officials:
affiliation: Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
name: zhang hong, ph.d
role: STUDY_CHAIR
References: