Ketamine Versus Propofol as ICU Sedation | NCT06243822

Studies
Ketamine Versus Propofol as ICU Sedation

NCT06243822

Sponsor

Menoufia University

Status

Completed

Last Update Posted

Feb 6, 2024Actual

Enrollment

100Actual

Phase

Phase 4

Conditions

Ketamine
Propofol
Sedation
Mechanical Ventilation

Interventions

Ketamine
Propofol

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Jan 14, 2024

First Submission Date that Met QC Criteria

Jan 28, 2024

First Posted Date

Feb 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2024

Last Update Posted Date

Feb 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mostafa saieed fahim mansour, lecturer of anaesthesiology, Menoufia UniversityPrincipal Investigator

Lead Sponsor

Menoufia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

this study is to assess the hemodynamic profile of ketamine compared with propofol in critically ill, mechanically ventilated adult Patients study will be carried out on 100 mechanically ventilated patients who received one sedative agent propofol or ketamine The patients will be randomized into two equal groups to receive either ketamine or propofol Group 1 (Ketamine group): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation. Group 2 (Propofol group): Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6 mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve appropriate sedation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketamine group	Active Comparator		Drug: Ketamine
propofol group	Active Comparator		Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation.	Ketamine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heart rate	measure heart rate	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours
mean arterial blood pressure	measure mean arterial blodd pressure	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mechanically ventilated, and receive sedation with continuous infusion propofol, or ketamine for at least 24 hours

Exclusion Criteria:

Receiving propofol or ketamine concurrently.
- Transferred from an outside hospital on sedation.
- Receiving ketamine for an indication other than sedation.
- Daily intake of opioids.
- Contraindication to any drug used in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mostafa Saieed Mansour, MD	Menoufia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Menoufia University		Shibīn al Kawm	Menoufia	32511	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine
D015742	Propofol

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

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