Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy

NCT06215768 | Unknown Early Phase 1

• 1 other identifier: Emergency delirium
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary outcom Compare the effectiveness of study drugs on reducing the incidence of emergence delirium . Secondary outcomes: Sedation score Intensity of pain by FLACC Extubation time Iength of stay in Post anesthetic care unite (PACU ) Incidence of negative post operative behavioural changes (NPOBCs ) Laryngeospasm ny adverse effects

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• Emergency Delirium

  The incidence of emergence delirium in pediatrics undergoing tonsillectomy and adenoidectomy a prospective randomised clinical trial .

  30 minutes

Secondary Outcomes (1)

• FLACC

  30 minutes

Study Arms (2)

Dexemedetomidine group A

EXPERIMENTAL

Patients aged( 2\_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous dexmedetomidine 0.5 μg/kg

Drug: Dexmedetomidine and Midazolam

Midazolam group B

EXPERIMENTAL

Patients aged( 2\_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous midazolam 0.1 mg/kg

Drug: Dexmedetomidine and Midazolam

Interventions

Dexmedetomidine and Midazolam DRUG

This will be a prospective, double-blind, randomized controlled study conducted between October 2023and June 2024 . Patients aged( 2\_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous dexmedetomidine 0.5 μg/kg Or intravenous midazolam 0.1 mg /kg(Group A) or (Group B) over 10 minutes after induction of anesthesia. The primary outcome is the incidence of ED within 30 minutes after extubation. Other outcomes are the incidence of pain, extubation time, post-anesthesia care unit (PACU) length of stay after extubation, adverse events, and the incidence of negative postoperative behavioral changes (NPOBCs).

Dexemedetomidine group A; Midazolam group B

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Pediatric patients aged 2-12 years
• With ASA physical status 1 or 2
• Who were scheduled for tonsillectomy with and without adenoidectomy under general anesthesia

You may not qualify if:

• Emergency surgery
• Intellectual disability
• Neurological disease
• Renal , hepatic, cardiac or respiratory disease
• Allergy to the study drugs

Sponsors & Collaborators

• Esraa Abdel Azez Soltan Mohamed Zayed: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; 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)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mostafa Hassanen

  Department of anesthesia , intensive care and pain management

  STUDY DIRECTOR

Central Study Contacts

Esraa Abdel Azez, Master degree

CONTACT

01117296148; esraazayed38@gmail.com

Jehan Ahmed Sayed, Co-author

CONTACT

0100 6253939; jihan_sayed@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01