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

NCT ID: NCT06010927

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group-A; ketamine/midazolam premedication

Group Type ACTIVE_COMPARATOR

ketamine/midazolam

Intervention Type DRUG

premedication

Group-B: Ketofol pre-extubation

Group Type ACTIVE_COMPARATOR

Ketofol

Intervention Type DRUG

Pre-extubation

Interventions

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ketamine/midazolam

premedication

Intervention Type DRUG

Ketofol

Pre-extubation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abeer Ahmed, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abeer Ahmed

Maadi, Cairo Governorate, Egypt

Site Status RECRUITING

Anesthesia department - Faculty of medicine- Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abeer Ahmed

Role: CONTACT

01005244590

Facility Contacts

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Abeer Ahmed

Role: primary

01005244590

Other Identifiers

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MS-92-2023

Identifier Type: -

Identifier Source: org_study_id

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