Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
Primary Purpose
Femoral Neck Fractures, Postoperative Complications, Inflammatory Response
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
hip arthroplasty
Total Intravenous Anesthesia and Peripheral nerve blocks
Sponsored by
About this trial
This is an interventional prevention trial for Femoral Neck Fractures
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
Sites / Locations
- Anesthesia and Operation Center, Chinese People's Liberation Army General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexmedetomidine
Saline
Arm Description
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.
Participants in con group receive placebo(saline) as the same dose at the same time as dex group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Postoperative Delirium(PD)
The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)
Full Information
NCT ID
NCT01934049
First Posted
August 21, 2013
Last Updated
September 7, 2013
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01934049
Brief Title
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures, Postoperative Complications, Inflammatory Response, Postoperative Delirium, Postoperative Cognitive Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Participants in con group receive placebo(saline) as the same dose at the same time as dex group.
Intervention Type
Procedure
Intervention Name(s)
hip arthroplasty
Intervention Description
Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.
Intervention Type
Drug
Intervention Name(s)
Total Intravenous Anesthesia and Peripheral nerve blocks
Intervention Description
Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol
Primary Outcome Measure Information:
Title
postoperative cognitive dysfunction(POCD)
Description
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.
Time Frame
7days
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
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).
Time Frame
7days
Title
Postoperative Delirium(PD)
Description
The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
postoperative complications
Time Frame
7 days
Title
perioperative opioid consumption
Description
Intraoperative and postoperative opioid consumption were calculated between the two groups.
Time Frame
3 days
Title
IL-6 and C-reacting protein
Time Frame
7 days
Title
MB isoenzyme of creatine kinase and blood sugar
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang hong, ph.d
Phone
0086-10-66937462
Email
mazuimao301@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
yuan weixiu, ph.d
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhang hong, ph.d
Organizational Affiliation
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Hong, ph.d
Phone
0086-10-66937462
Email
mazuimao301@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yuan Weixiu, Ph.d
Phone
0086-10-66938052
Email
yuanweixiu301@126.com
First Name & Middle Initial & Last Name & Degree
Gong Maowei, MD
First Name & Middle Initial & Last Name & Degree
Zhao Ying, MD
12. IPD Sharing Statement
Learn more about this trial
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
We'll reach out to this number within 24 hrs