Actively Recruiting

Phase 4
Age: 60Years +
All Genders
ID06579001

Effect of Nasal Spray Dexmedetomidine on Preventing Emergence Delirium in Elderly Patients Undergoing Total Hip Replacement with General Anesthesia

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-23

264

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Emergence Delirium (ED) is a common complication after surgery, characterized by sudden problems with attention and consciousness during recovery from general anesthesia. It can increase risks such as self-injury, wound reopening, accidental catheter removal, postoperative delirium, cognitive decline, and higher medical resource use after discharge. This study focuses on elderly patients undergoing total hip replacement, aiming to evaluate how nasal spray dexmedetomidine might prevent ED in this group. Participants will receive either a nasal spray of dexmedetomidine or a saline placebo at a dose of 100 micrograms, assigned according to their study group. The study compares this nasal administration with previous intravenous methods, which have shown drawbacks like delayed extubation and prolonged recovery room stays. Nasal spray dexmedetomidine offers potentially better stability and fewer side effects, making it a promising approach to reduce ED after hip replacement under general anesthesia. During the study, researchers will monitor patients closely for signs of emergency delirium following surgery. Assessments will include evaluations in the post-anesthesia care unit to avoid missing delirium cases. The primary outcome is the occurrence of postoperative emergency delirium. The study involves elderly adults aged 60 and above and includes safety monitoring and follow-up during the hospital stay to understand the treatment's effects comprehensively.

CONDITIONS

Official Title

Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Scheduled for total hip arthroplasty under general anesthesia
  • Classified as ASA physical status II or III
  • Provided informed consent or consent obtained from guardian
Not Eligible

You will not qualify if you...

  • Allergy or contraindication to dexmedetomidine
  • Severe rhinitis or nasal deformity
  • Severe bradycardia (heart rate less than 50 beats per minute) or grade 2 or higher atrioventricular block
  • Permanent pacemaker implantation
  • Severe heart failure or ejection fraction less than 30%
  • History of myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency
  • Emergency surgery
  • Severe liver or kidney dysfunction (Child-Pugh class B or C, CKD stage 3 to 5)
  • Preexisting mental illness, cognitive impairment, or communication difficulties preventing evaluation
  • Presence of delirium before surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

闗闗

Hangzhou, China

Actively Recruiting

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Research Team

M

Min Yan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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