Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

NCT01934049 | Unknown Phase 4 DMC

• 1 other identifier: Dex-THR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Postoperative recovery

  7days

• Postoperative Delirium(PD)

  72 hours

Other Outcomes (4)

• postoperative complications

  7 days

• perioperative opioid consumption

  3 days

• IL-6 and C-reacting protein

  7 days

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks

Saline

PLACEBO COMPARATOR

Participants in con group receive placebo(saline) as the same dose at the same time as dex group.

Procedure: hip arthroplasty; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks

Interventions

hip arthroplasty PROCEDURE

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

Dexmedetomidine; Saline

Total Intravenous Anesthesia and Peripheral nerve blocks DRUG

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

Dexmedetomidine; Saline

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures; Postoperative Complications; Emergence Delirium; Postoperative Cognitive Complications

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• zhang hong, ph.d

  Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital

  STUDY CHAIR

Central Study Contacts

zhang hong, ph.d

CONTACT

0086-10-66937462; mazuimao301@yahoo.com.cn

yuan weixiu, ph.d

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

CN (1)