Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01934049
• Other study ID #: Dex-THR
• Status: Recruiting
• Phase: Phase 4
• First received: August 21, 2013
• Last updated: September 7, 2013
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2013
• Source: Chinese PLA General Hospital
• Contact: zhang hong, ph.d
• Phone: 0086-10-66937462
• Email: mazuimao301[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Femoral Neck Fractures
• Inflammatory Response
• Postoperative Cognitive Dysfunction
• Postoperative Complications
• Postoperative Delirium

Intervention

Procedure:
• hip arthroplasty
Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.

Drug:
• Total Intravenous Anesthesia and Peripheral nerve blocks
Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol

Locations

Country	Name	City	State
China	Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complications		7 days	Yes
Other	perioperative opioid consumption	Intraoperative and postoperative opioid consumption were calculated between the two groups.	3 days	Yes
Other	IL-6 and C-reacting protein		7 days	Yes
Other	MB isoenzyme of creatine kinase and blood sugar		7 days	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	Postoperative Delirium(PD)	The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)	72 hours	Yes