Delirium
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGNasal spray dexmedetomidine
Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥60 years old 2. Total hip arthroplasty under general anesthesia 3. ASA II-III 4. Informed consent was obtained from patients or their guardians
Exclusion criteria
1. Allergy or contraindication to dexmedetomidine 2. Severe rhinitis and nasal deformity 3. 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% 4. Patients with previous myocardial infarction, unstable angina pectoris, severe arrhythmia, and cardiac insufficiency 5. Emergency surgery 6. Severe hepatic and renal dysfunction (Child-Pugh class B and C, CKD3-5) 7. Preoperative mental illness, cognitive impairment, and communication difficulties could not be evaluated in the study 8. Preoperative delirium was present
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| emergency delirium | postoperative | RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | postoperative 3 days | 3D-CAM,delirium was judged according to whether there were positive features in the questionnaire |
| time to extubation | postoperative 3 days | time to extubation |
| PACU stay | postoperative 3 days | length of PACU stay |
| Preoperative anxiety score | preoperative | Perioperative anxiety scale，PAS-7, score range: 0-28, higher score means more anxiety |
| PONV | postoperative 3 days | the incidence of nausea and /or vomiting |
| sleep quality | postoperative 3 days | RCSQ, 0-100, higher score means higher sleep quality |
| Pain score | postoperative 3 days | NRS, 0-10, 0 means no pain, 10 means severe pain |
| Hemodynamic changes | introperative | between drug administration and anesthesia introduction |
Countries
China
Contacts
Primary ContactMin Yan
Outcome results
None listed