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

NCT06010927 | Unknown Phase 4

• 1 other identifier: MS-92-2023
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• incidence of Emergence agitation

  starting from time of PACU admission after recover from anesthesia till 6 hours postoperative

Study Arms (2)

Group-A; ketamine/midazolam premedication

ACTIVE COMPARATOR

Drug: ketamine/midazolam

Group-B: Ketofol pre-extubation

ACTIVE COMPARATOR

Drug: Ketofol

Interventions

ketamine/midazolam DRUG

premedication

Group-A; ketamine/midazolam premedication

Ketofol DRUG

Pre-extubation

Group-B: Ketofol pre-extubation

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Abeer Ahmed

Maadi, Cairo Governorate, 11562, Egypt

RECRUITING

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Abeer Ahmed

CONTACT

01005244590; abeer_ahmed@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: August 25, 2023
• Study Start: August 25, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

EG (2)