Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries

NCT06545890 | Recruiting Phase 1 DMC

• 1 other identifier: MD-184-2023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery, in comparison to dexmedetomidine.

Conditions

Emergence Delirium

Keywords

ketofol; dexmedetomidine; squint surgeries; children

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups.

  During their stay at PACU, delirium will be assessed at 5, 10, 15, 20, 25, and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale (PAED) . ED will be established when the child have a score of 10 or more. If the child has a score of 10 or more, rescue sedation will be done via propofol 1 mg/kg .

  PAED score immediately after admission to PACU .

Study Arms (2)

Ketofol Group

EXPERIMENTAL

Five minutes after induction; Ketofol (ketamine to propofol ratio 1:4) will be infused at a rate of 0.6 ml/kg/hr. Ketofol will be prepared by adding 40 mg of ketamine to 160 mg of propofol and diluted to 20 ml with normal saline 0.9%.

Drug: Ketamine

Dexmedetomidine

EXPERIMENTAL

Five minutes after securing the airway, dexmedetomidine infusion will be started at a rate of 0.2 mcg/kg/hr.

Drug: Dexmedetomidine

Interventions

Ketamine DRUG

continous infusion during surgery

Also known as: propofol

Ketofol Group

Dexmedetomidine DRUG

continous infusion during surgery

Dexmedetomidine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All pediatric patients aged 2 to 6 years.
• Both sexes.
• ASA physical status I and II.
• Patients undergoing squint surgery.

You may not qualify if:

• Refusal of parents.
• Patient sensitivity to any of the study medications.
• Known neurological disease that can affect the assessment of ED postoperatively.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Abu Elresh Hospitals ( Cairo university )

Cairo, Egypt

RECRUITING

Abu ElResh hospital

Cairo, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ketamine; Propofol; Dexmedetomidine

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; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Karim K Fahim

  Professor of Anesthesia, Pain management and Surgical ICU Faculty of Medicine, Cairo University.

  STUDY DIRECTOR

Central Study Contacts

Muhammad Kh Ibrahim

CONTACT

+201032170260; dr.mki26413@gmail.com

Mohamed El Abdelfatah

CONTACT

+201272288695; mohyaseen2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: double blinded

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 9, 2024
• Study Start: August 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 10, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)