Effect of Ketamine/Midazolam Premedication Versus Pre-ext... | NCT06010927

Studies
Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

NCT06010927

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 15, 2023Actual

Enrollment

140Estimated

Phase

Phase 4

Conditions

Emergence Delirium

Interventions

ketamine/midazolam
Ketofol

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2023Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jun 28, 2023

First Submission Date that Met QC Criteria

Aug 24, 2023

First Posted Date

Aug 25, 2023Actual

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

Sep 14, 2023

Last Update Posted Date

Sep 15, 2023Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia.

The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile.

Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV.

This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.

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

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group-A; ketamine/midazolam premedication	Active Comparator		Drug: ketamine/midazolam
Group-B: Ketofol pre-extubation	Active Comparator		Drug: Ketofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ketamine/midazolam	Drug	premedication	Group-A; ketamine/midazolam premedication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of Emergence agitation		starting from time of PACU admission after recover from anesthesia till 6 hours postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status I or II
Children scheduled for AT under general anesthesia (GA).

Exclusion Criteria:

Congenital cardiovascular anomalies
Behavioral changes
Delayed physical development
Children receiving sedatives or anticonvulsants therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abeer Ahmed	Contact	01005244590		abeer_ahmed@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abeer Ahmed	Recruiting	Maadi	Cairo Governorate	11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine
D008874	Midazolam

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided