Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy

E

Esraa Abdel Azez Soltan Mohamed Zayed

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Emergence Delirium

Treatments

Drug: Dexmedetomidine and Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT06215768
Emergency delirium

Details and patient eligibility

About

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

Full 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 . .

Enrollment

100 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Dexemedetomidine group A
Experimental group
Description:
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
Treatment:
Drug: Dexmedetomidine and Midazolam
Midazolam group B
Experimental group
Description:
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
Treatment:
Drug: Dexmedetomidine and Midazolam

Trial contacts and locations

0

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Central trial contact

Esraa Abdel Azez, Master degree; Jehan Ahmed Sayed, Co-author

Data sourced from clinicaltrials.gov

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