Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06215768
Other study ID # Emergency delirium
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date January 2024
Est. completion date October 2024

Study information

Verified date January 2024
Source Assiut University
Contact Esraa Abdel Azez, Master degree
Phone 01117296148
Email esraazayed38@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Esraa Abdel Azez Soltan Mohamed Zayed

Outcome

Type Measure Description Time frame Safety issue
Primary Emergency Delirium The incidence of emergence delirium in pediatrics undergoing tonsillectomy and adenoidectomy a prospective randomised clinical trial . 30 minutes
Secondary FLACC Measure of intensity of pain by face , legs ,activity Cry , consolability 30 minutes
See also
  Status Clinical Trial Phase
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Completed NCT03788564 - The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Recruiting NCT01221025 - Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain Phase 4
Not yet recruiting NCT06035757 - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery Phase 4
Not yet recruiting NCT04291820 - Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence N/A
Completed NCT05124067 - Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children Phase 1
Recruiting NCT05091242 - The PREVENT AGITATION Trial II - Children ≤1 Year Phase 2/Phase 3
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Completed NCT04531020 - Incidence of Emergence Delirium in the PACU
Completed NCT05105178 - Verbal Stimulation of Orientation on Emergence Agitation N/A
Completed NCT03285243 - Effect of Monochromatic Light on Incidence of Emergence Delirium in Children N/A
Recruiting NCT04621305 - Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia Phase 4
Completed NCT01096797 - Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children Phase 4
Recruiting NCT03330613 - Emergence Delirium and Recovery Time in Children N/A
Completed NCT05872087 - Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries Phase 1
Recruiting NCT06326983 - Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery N/A
Not yet recruiting NCT06387953 - Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy N/A
Not yet recruiting NCT06406257 - Temperature Management on Postoperative Delirium N/A
Not yet recruiting NCT05883280 - The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery N/A
Not yet recruiting NCT05821972 - Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate Phase 4