闗闗
Hangzhou, China
Location status: Recruiting
Location contact
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NCT Number: NCT06579001
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 4
Hangzhou, China
Location status: Recruiting
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nasal spray dexmedetomidine or saline was used 100ug per patient acording to the group assignment
Other names: saline
Time frame: postoperative
RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire
Time frame: preoperative
Perioperative anxiety scale,PAS-7, score range: 0-28, higher score means more anxiety
Time frame: postoperative 3 days
3D-CAM,delirium was judged according to whether there were positive features in the questionnaire
Time frame: postoperative 3 days
time to extubation
Time frame: postoperative 3 days
length of PACU stay
Time frame: introperative
between drug administration and anesthesia introduction
Time frame: postoperative 3 days
the incidence of nausea and /or vomiting
Time frame: postoperative 3 days
RCSQ, 0-100, higher score means higher sleep quality
Time frame: postoperative 3 days
NRS, 0-10, 0 means no pain, 10 means severe pain
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia: a Randomized Clinical Trial
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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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