Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368219
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-29
Brief Title:
Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups
Group A 25 patients will receive ketamine 05 mgkg plus midazolam 005 mgkg
Group B 25 patients will receive ketamine 05 mgkg plus propofol 05 mgkg Additional ketamine 025 mgkg will be administered in case of inadequate sedation in both groups
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia SIVA international sedation task force to standardize reporting adverse events
Group A 25 patients will receive ketamine 05 mgkg plus midazolam 005 mgkg
Group B 25 patients will receive ketamine 05 mgkg plus propofol 05 mgkg Additional ketamine 025 mgkg will be administered in case of inadequate sedation in both groups
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia SIVA international sedation task force to standardize reporting adverse events
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