Clinical trial NCT06215768: Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Emergence Delirium
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 . .

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

Primary outcomes:
measure: Emergency Delirium
timeFrame: 30 minutes
Secondary outcomes:
measure: FLACC
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Department of anesthesia , intensive care and pain management
name: Mostafa Hassanen
role: STUDY_DIRECTOR
References: