Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131375
• Other study ID #: Dexmedetomidine.1.2017
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: July 2018
• Source: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Delirium
• Emergence Delirium
• Extubation Time
• Heart Rate
• Postoperative Analgesia

Intervention

Drug:
• Dexmedetomidine
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.
• Normal saline
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.

Device:
• Bispectral index
Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
• Train of four ratio
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

Locations

Country	Name	City	State
Greece	Childrens Hospital P. and A. Kyriakou Anesthesiology Department	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence delirium in PACU	Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale	up to 30 min
Secondary	Emergence delirium severity, assessed in PACU	Watcha score	up to 30 min
Secondary	Extubation time	time interval between discontinuation of anesthetics and extubation	up to15 min
Secondary	Heart rate	monitored intraoperatively ECG	up to 45 min
Secondary	Blood pressure	monitored intraoperatively NIBP	up to 45 min