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Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01934049
Enrollment
80
Registered
2013-09-04
Start date
2013-09-30
Completion date
2014-06-30
Last updated
2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREhip arthroplasty

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

DRUGTotal Intravenous Anesthesia and Peripheral nerve blocks

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

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative cognitive dysfunction(POCD)7daysPOCD 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.

Secondary

MeasureTime frameDescription
Postoperative recovery7daysThe 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).
Postoperative Delirium(PD)72 hoursThe postoperative Delirium is assessed by the Confusion Assessment Method (CAM)

Other

MeasureTime frameDescription
postoperative complications7 days
MB isoenzyme of creatine kinase and blood sugar7 days
perioperative opioid consumption3 daysIntraoperative and postoperative opioid consumption were calculated between the two groups.
IL-6 and C-reacting protein7 days

Countries

China

Contacts

Primary Contactzhang hong, ph.d
mazuimao301@yahoo.com.cn0086-10-66937462
Backup Contactyuan weixiu, ph.d

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026