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NCT06010927 Clinical Trial

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

Emergence Delirium Clinical Trial

Official title:
Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06010927
Other study ID # MS-92-2023
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 25, 2023
Est. completion date December 2023

Study information
Verified date September 2023
Source Cairo University
Contact Abeer Ahmed
Phone 01005244590
Email abeer_ahmed@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ketamine/midazolam
premedication
• Ketofol
Pre-extubation

Locations
Country Name City State
Egypt Anesthesia department - Faculty of medicine- Cairo University Cairo
Egypt Abeer Ahmed Maadi Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of Emergence agitation starting from time of PACU admission after recover from anesthesia till 6 hours postoperative
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