Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Study Overview
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Brief Summary
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Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .

Official Title
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Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.

Conditions
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Emergence Delirium, Extubation Time, Heart Rate, Postoperative Analgesia, Blood Pressure

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Normal saline
* Device: Bispectral index
* Device: Train of four ratio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ASA I or II tonsillectomy with or without adenoidectomy Exclusion Criteria: Allergy to dexmedetomidine Allergy to anesthetic drugs History of neurological disease History of neuromuscular disease History of renal disease History of hepatic disease craniofacial anomalies History of cardiac disease History of respiratory disease

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>In Group A: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group A receives a 50 ml NS infusion containing the drug Dexmedetomidine 1 mcg kg-1 slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.16 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio. | Drug: Dexmedetomidine<br>* Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.<br>* Other names: alpha-2 agonist;Device: Bispectral index<br>* Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60<br>* Other names: BIS;Device: Train of four ratio<br>* Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure<br>* Other names: TOF-Watch;|
| Placebo Comparator: Group B<br>In Group B: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group B receives a volume matched normal saline infusion slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.2 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio. | Drug: Normal saline<br>* Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group B receives a volume matched Normal saline infusion. Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index, Train of four ratio.<br>* Other names: placebo;Device: Bispectral index<br>* Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60<br>* Other names: BIS;Device: Train of four ratio<br>* Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure<br>* Other names: TOF-Watch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium in PACU | Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale | up to 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium severity, assessed in PACU | Watcha score | up to 30 min | 
| Extubation time | time interval between discontinuation of anesthetics and extubation | up to15 min | 
| Heart rate | monitored intraoperatively ECG | up to 45 min | 
| Blood pressure | monitored intraoperatively NIBP | up to 45 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, children, dexmedetomidine, emergence delirium, anesthesia