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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex group | Experimental | at least 20 min before the introduction of anesthesia, the patient takes the sitting position, the head is slightly tilted forward, and the product is kept upright. Insert the nostril at the same Angle as the nasal cavity. Press down on the spray pump evenly with the index and middle fingers at the same time, and press the pump to the bottom at one time for 1 spray (25ug). After 1 spray on both nostrils, tilt your head back slightly and inhale gently. After staying for about 30 s, 1 spray was applied to each nostril on both sides for a total of 4 sprays (100ug). |
|
| Saline group | Placebo Comparator | Normal saline packaged in the same appearance was used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal spray dexmedetomidine | Drug | Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| emergency delirium | RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire | postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative anxiety score | Perioperative anxiety scale,PAS-7, score range: 0-28, higher score means more anxiety | preoperative |
| Postoperative delirium | 3D-CAM,delirium was judged according to whether there were positive features in the questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Yan | Contact | 0571-87783759 | zryanmin@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Yan | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| é——é—— | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| postoperative 3 days |
| time to extubation | time to extubation | postoperative 3 days |
| PACU stay | length of PACU stay | postoperative 3 days |
| Hemodynamic changes | between drug administration and anesthesia introduction | introperative |
| PONV | the incidence of nausea and /or vomiting | postoperative 3 days |
| sleep quality | RCSQ, 0-100, higher score means higher sleep quality | postoperative 3 days |
| Pain score | NRS, 0-10, 0 means no pain, 10 means severe pain | postoperative 3 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D017670 |
| Sodium Compounds |