Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01934049

Dex-THR

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

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.

Treatment:

Drug: Total Intravenous Anesthesia and Peripheral nerve blocks

Procedure: hip arthroplasty

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Total Intravenous Anesthesia and Peripheral nerve blocks

Procedure: hip arthroplasty