Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

NCT ID: NCT01934049

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

hip arthroplasty

Intervention Type PROCEDURE

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

Total Intravenous Anesthesia and Peripheral nerve blocks

Intervention Type DRUG

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

Saline

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

Group Type PLACEBO_COMPARATOR

hip arthroplasty

Intervention Type PROCEDURE

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

Total Intravenous Anesthesia and Peripheral nerve blocks

Intervention Type DRUG

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

Interventions

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hip arthroplasty

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

Intervention Type PROCEDURE

Total Intravenous Anesthesia and Peripheral nerve blocks

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junle Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zhang hong, ph.d

Role: STUDY_CHAIR

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

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhang hong, ph.d

Role: CONTACT

Phone: 0086-10-66937462

Email: [email protected]

yuan weixiu, ph.d

Role: CONTACT

Facility Contacts

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Zhang Hong, ph.d

Role: primary

Yuan Weixiu, Ph.d

Role: backup

Other Identifiers

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Dex-THR

Identifier Type: -

Identifier Source: org_study_id