Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

NCT03131375 | Completed Phase 2

• 1 other identifier: Dexmedetomidine.1.2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

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

Keywords

dexmedetomidine; emergence delirium; anesthesia; propofol; children

Outcome Measures

Primary Outcomes (1)

• Emergence delirium in PACU

  Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale

  up to 30 min

Secondary Outcomes (4)

• Emergence delirium severity, assessed in PACU

  up to 30 min

• Extubation time

  up to15 min

• Heart rate

  up to 45 min

• Blood pressure

  up to 45 min

Study Arms (2)

Group A

ACTIVE COMPARATOR

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; Device: Bispectral index; Device: Train of four ratio

Group B

PLACEBO COMPARATOR

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; Device: Bispectral index; Device: Train of four ratio

Interventions

Dexmedetomidine DRUG

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.

Also known as: alpha-2 agonist

Group A

Normal saline DRUG

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.

Also known as: placebo

Group B

Bispectral index DEVICE

Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60

Also known as: BIS

Group A; Group B

Train of four ratio DEVICE

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

Also known as: TOF-Watch

Group A; Group B

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Athens General Children's Hospital "Pan. & Aglaia Kyriakou": lead

Study Sites (1)

Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Athens, 11526, Greece

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Adrenergic alpha-2 Receptor Agonists; Saline Solution; Consciousness Monitors

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Surgical Equipment; Equipment and Supplies

Study Officials

• Evangelia Kalliardou, Consultant

  Director of the Anesthesiology Dept.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of the Anesthesiology Dept, MD, PhD

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 27, 2017
• Study Start: May 1, 2017
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: July 9, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)