Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Phase 2

Completed

• Conditions: Emergence Delirium; Blood Pressure; Extubation Time; Postoperative Analgesia; Heart Rate
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine; Device: Bispectral index; Device: Train of four ratio

• Registration Number: NCT03131375
• Lead Sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Brief Summary

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Start: 2017-05-01
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children
• ASA I or II
• tonsillectomy with or without adenoidectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Bispectral index	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.
Group A	Train of four ratio	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.
Group B	Normal saline	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.
Group B	Bispectral index	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.
Group B	Train of four ratio	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.
Group A	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Emergence delirium in PACU	up to 30 min	Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Childrens Hospital P. and A. Kyriakou Anesthesiology Department; 🇬🇷 Athens, Greece