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

Phase 4

Recruiting

• Conditions: Emergence Delirium
• Interventions: Drug: ketamine/midazolam; Drug: Ketofol

• Registration Number: NCT06010927
• Lead Sponsor: Cairo University

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 available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-08-24
• Study Start: 2023-08-25
• Study First Posted: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-A; ketamine/midazolam premedication	ketamine/midazolam	-
Group-B: Ketofol pre-extubation	Ketofol	-

Primary Outcome Measures

Name	Time	Method
incidence of Emergence agitation	starting from time of PACU admission after recover from anesthesia till 6 hours postoperative

Trial Locations

Locations (2)

Abeer Ahmed; 🇪🇬 Maadi, Cairo, Egypt

Anesthesia department - Faculty of medicine- Cairo University; 🇪🇬 Cairo, Egypt