Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579001
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Nasal Spray Dexmedetomidine on Emergence Delirium Prevention in Total Hip Replacement in the Elderly Under General Anesthesia A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 13 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None