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NCT Number: NCT06579001

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

闗闗

Hangzhou, China

Location status: Recruiting

Location contact

About this study

The incidence of hip fracture after surgery in patients over 55 years old is about 45%, and ED is highly predictive of delirium during postoperative hospitalization, which occurs in about 1/3 of ED patients during postoperative hospitalization.

It has been suggested that if delirium is monitored only on the first postoperative day and not at the PACU stage, up to 53% of delirium cases may be missed.

Studies have shown that perioperative application of dexmedetomidine can reduce the risk of postoperative delirium to a certain extent. However, intravenous dexmedetomidine usually leads to problems with delayed extubation, residual sedation, and prolonged PACU stay.

Previous studies have shown that intranasal dexmedetomidine improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing laparoscopic gynecologic surgery. Compared with intravenous administration, intranasal administration of dexmedetomidine resulted in milder hemodynamic fluctuations. However, stable nasal spray bioavailability is superior to intravenous dosage forms for nasal use.

Based on the above background, this study aims to investigate the effect of nasal spray of dexmedetomidine on the prevention of emergence delirium after total hip replacement in elderly patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Nasal spray dexmedetomidine

Drug

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

Other names: saline

Primary outcomes

  1. emergency delirium

    Time frame: postoperative

    RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire

Secondary outcomes

  1. Preoperative anxiety score

    Time frame: preoperative

    Perioperative anxiety scale,PAS-7, score range: 0-28, higher score means more anxiety

  2. Postoperative delirium

    Time frame: postoperative 3 days

    3D-CAM,delirium was judged according to whether there were positive features in the questionnaire

  3. time to extubation

    Time frame: postoperative 3 days

    time to extubation

  4. PACU stay

    Time frame: postoperative 3 days

    length of PACU stay

  5. Hemodynamic changes

    Time frame: introperative

    between drug administration and anesthesia introduction

  6. PONV

    Time frame: postoperative 3 days

    the incidence of nausea and /or vomiting

  7. sleep quality

    Time frame: postoperative 3 days

    RCSQ, 0-100, higher score means higher sleep quality

  8. Pain score

    Time frame: postoperative 3 days

    NRS, 0-10, 0 means no pain, 10 means severe pain

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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