RecruitingPhase 4NCT06579001

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

Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia: a Randomized Clinical Trial


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

264 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Emergence Delirium (ED) is a common postoperative complication refers to an acute brain dysfunction that occurs during the recovery from general anesthesia, which is mainly characterized by sudden attention and consciousness disorders. The occurrence of ED increases the risk of self-injury, wound dehiscence, accidental catheter dislocation, and postoperative delirium, and is also associated with postoperative cognitive deterioration and increased utilization of medical resources after discharge.


Eligibility

Min Age: 60 Years

Inclusion Criteria4

  • Age ≥60 years old
  • Total hip arthroplasty under general anesthesia
  • ASA II-III
  • Informed consent was obtained from patients or their guardians

Exclusion Criteria8

  • Allergy or contraindication to dexmedetomidine
  • Severe rhinitis and nasal deformity
  • Severe bradycardia (heart rate \<50 beats/minute) or atrioventricular block of grade 2 or higher, permanent pacemaker implantation, severe heart failure or ejection fraction \<30%
  • Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency
  • Emergency surgery
  • Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5)
  • Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study
  • Preoperative delirium was present

Interventions

DRUGNasal spray dexmedetomidine

Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment


Locations(1)

闗闗

Hangzhou, China

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NCT06579001


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