Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Junle Liu, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01934049
First received: August 21, 2013
Last updated: September 7, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Femoral Neck Fractures
Postoperative Complications
Inflammatory Response
Postoperative Delirium
Postoperative Cognitive Dysfunction
Procedure: hip arthroplasty
Drug: Total Intravenous Anesthesia and Peripheral nerve blocks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • postoperative cognitive dysfunction(POCD) [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Postoperative recovery [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
    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).

  • Postoperative Delirium(PD) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)


Other Outcome Measures:
  • postoperative complications [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • perioperative opioid consumption [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Intraoperative and postoperative opioid consumption were calculated between the two groups.

  • IL-6 and C-reacting protein [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • MB isoenzyme of creatine kinase and blood sugar [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine
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
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
Placebo Comparator: Saline
Participants in con group receive placebo(saline) as the same dose at the same time as dex group.
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934049

Contacts
Contact: zhang hong, ph.d 0086-10-66937462 mazuimao301@yahoo.com.cn
Contact: yuan weixiu, ph.d

Locations
China
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital Recruiting
Beijing, China, 100853
Contact: Zhang Hong, ph.d    0086-10-66937462    mazuimao301@yahoo.com.cn   
Contact: Yuan Weixiu, Ph.d    0086-10-66938052    yuanweixiu301@126.com   
Sub-Investigator: Gong Maowei, MD         
Sub-Investigator: Zhao Ying, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: zhang hong, ph.d Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
  More Information

No publications provided

Responsible Party: Junle Liu, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01934049     History of Changes
Other Study ID Numbers: Dex-THR
Study First Received: August 21, 2013
Last Updated: September 7, 2013
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Postoperative Complications
Cognition Disorders
Wounds and Injuries
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Hip Fractures
Femoral Fractures
Leg Injuries
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014