Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398275
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-29
Brief Title:
Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty FESS or Septoplasty
Sponsor:
University Hospital of Split
Organization:
University Hospital of Split
Study Overview
Official Title:
Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty FESS or Septoplasty
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries septoplasty rhinoseptoplasty or functional endoscopic sinus surgery
Patients aged 18-65 ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups The first group will receive remimazolam before anesthesia while the second will receive normal saline solution
The main outcome of the study will be the presenceabsence of delirium during anesthesia recovery while the secondary outcome will be the postoperative pain level the length of stay in the recovery room the presence of unwanted events in the recovery room and the presence of postoperative mood changes
Patients aged 18-65 ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups The first group will receive remimazolam before anesthesia while the second will receive normal saline solution
The main outcome of the study will be the presenceabsence of delirium during anesthesia recovery while the secondary outcome will be the postoperative pain level the length of stay in the recovery room the presence of unwanted events in the recovery room and the presence of postoperative mood changes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None