Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy

NCT ID: NCT06215768

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-10-31

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

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 . .

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dexmedetomidine and Midazolam

Intervention Type: 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).

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

Group Type: EXPERIMENTAL

Dexmedetomidine and Midazolam

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Esraa Abdel Azez Soltan Mohamed Zayed

OTHER

Sponsor Role: lead

Responsible Party

Esraa Abdel Azez Soltan Mohamed Zayed

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mostafa Hassanen

Role: STUDY_DIRECTOR

Department of anesthesia , intensive care and pain management

Central Contacts

Esraa Abdel Azez, Master degree

Role: CONTACT

esraazayed38@gmail.com

01117296148

Jehan Ahmed Sayed, Co-author

Role: CONTACT

jihan_sayed@aun.edu.eg

0100 6253939

Other Identifiers

Emergency delirium

Identifier Type: -

Identifier Source: org_study_id