Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy

Comparative Study of Preoperative Intravenous Dexmedetomidine Versus Preoperative Intravenous Midazolam On the Incidence of Emergency Delirium in Pediatric Patients Undergoing Tonsillictomy and Adenoidectomy a Prospective Randomized Clincal Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Emergence Delirium
• Intervention / Treatment: Drug: Dexmedetomidine and Midazolam

Detailed Description

Emergence delirium (ED) is a common neurologic complication that can not only distress children and their families in the early postanesthetic period, but can also have adverse effects on children in the long-term Emergence delirium (ED) is an acute confusion state during recovery from anesthesia; patients with ED may present with disorientation, hallucination, restlessness, and purposeless hyperactive physical behavior . ED is not fully equivalent to EA; ED can involve hypoactive signs or mixed forms and hyperactive signs similar to agitation . Nevertheless, the terms EA and ED have been used interchangeably in several studies Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of POED, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics.

Postoperative emergence delirium develops in 12% to 18% of all children undergoing general anesthesia for surgery.

dexmedetomidine, is a selective alpha-2 agonist, which works in the brain and spinal cord that has sedative, analgesic and anxiolytic properties. Dexmedetomidine also has the ability to lower the overall anesthetic requirements by reducing sympathetic outflow in response to painful surgical stimulation.

Midazolam is a widely used intravenous anesthetic agent with rapid onset, short duration of action and relatively rapid plasma clearance. It is mainly used to produce preoperative sedation and the induction of general anesthesia The action of midazolam can be explained through its action on gammaaminobutyric acid (GABA) receptors. GABA receptors mediate inhibitory neurotransmission in the central nervous system In our study we aim to compares the effectiveness of preoperative intravenous dexmedetomidine versus intravenous midazolam for the prevention of emergence delirium in pediatric patients undergoing tonsillectomy , adenoidectomy or both . .

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Esraa Abdel Azez, Master degree; Phone Number: 01117296148; Email: esraazayed38@gmail.com
• Study Contact Backup: Name: Jehan Ahmed Sayed, Co-author; Phone Number: 0100 6253939; Email: jihan_sayed@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

• Emergency surgery

Intellectual disability

Neurological disease

Renal , hepatic, cardiac or respiratory disease

Allergy to the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexemedetomidine group A; 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; 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).
Experimental: Midazolam group B; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Delirium	The incidence of emergence delirium in pediatrics undergoing tonsillectomy and adenoidectomy a prospective randomised clinical trial .	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC	Measure of intensity of pain by face , legs ,activity Cry , consolability	30 minutes

Collaborators and Investigators

• Sponsor: Esraa Abdel Azez Soltan Mohamed Zayed
• Investigators: Study Director: Mostafa Hassanen, Department of anesthesia , intensive care and pain management

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Emergencies; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Emergency delirium

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No