Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217055
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-11-22
Brief Title:
Comparison of Remimazolam-based MAC With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB a Randomized Controlled Trial
Status:
NOT_YET_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:
In patients undergoing transurethral resection of bladder the effect of remimazolam-based monitored anesthesia care MAC and inhalational general anesthesia will be compared under guidance by analgesia nociception index ANI monitoring Anesthesia time operation time anesthesia time excluding operation time and total dose of opioid will be compared
Detailed Description:
In remimazolam-based MAC group anesthesia will be induced with remimazolam and spontaneous breathing will be maintained The dose of remimazolam and remifentanil will be adjusted according to the patient state index PSI and the analgesia nociception indexANI
In inhalation general anesthesia group anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil Mechanical ventilation will be maintained by inserting laryngeal mask airway LMA or endotracheal tube The doses of sevoflurane and remifentanil will be adjusted according to the patient state index PSI and the analgesia nociception indexANI
Surgery cost anesthesia cost patient and surgeons satisfaction score pain score PONV score and the incidence of hypotension and hypoxemia will be compared
In inhalation general anesthesia group anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil Mechanical ventilation will be maintained by inserting laryngeal mask airway LMA or endotracheal tube The doses of sevoflurane and remifentanil will be adjusted according to the patient state index PSI and the analgesia nociception indexANI
Surgery cost anesthesia cost patient and surgeons satisfaction score pain score PONV score and the incidence of hypotension and hypoxemia will be compared
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?:
None
Is an FDA AA801 Violation?:
None