Emergency Delirium in Pediatrics Undergoing Tonsillectomy and Adenoidectomy
- Conditions
- Emergence Delirium
- Interventions
- Registration Number
- NCT06215768
- Lead Sponsor
- Esraa Abdel Azez Soltan Mohamed Zayed
- 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 . .
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Emergency surgery
Intellectual disability
Neurological disease
Renal , hepatic, cardiac or respiratory disease
Allergy to the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Midazolam group B Dexmedetomidine and Midazolam 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 Dexemedetomidine group A Dexmedetomidine and Midazolam 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
- Primary Outcome Measures
Name Time Method Emergency Delirium 30 minutes The incidence of emergence delirium in pediatrics undergoing tonsillectomy and adenoidectomy a prospective randomised clinical trial .
- Secondary Outcome Measures
Name Time Method FLACC 30 minutes Measure of intensity of pain by face , legs ,activity Cry , consolability