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Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Primary Purpose

Emergence Delirium, Extubation Time, Heart Rate

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Bispectral index
Train of four ratio
Sponsored by
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring dexmedetomidine, emergence delirium, anesthesia, propofol, children

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Emergence delirium severity, assessed in PACU
Watcha score
Extubation time
time interval between discontinuation of anesthetics and extubation
Heart rate
monitored intraoperatively ECG
Blood pressure
monitored intraoperatively NIBP

Full Information

First Posted
April 20, 2017
Last Updated
July 5, 2018
Sponsor
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
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1. Study Identification

Unique Protocol Identification Number
NCT03131375
Brief Title
Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia
Official Title
Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium, Extubation Time, Heart Rate, Postoperative Analgesia, Blood Pressure
Keywords
dexmedetomidine, emergence delirium, anesthesia, propofol, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
alpha-2 agonist
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
placebo
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Bispectral index
Other Intervention Name(s)
BIS
Intervention Description
Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
Intervention Type
Device
Intervention Name(s)
Train of four ratio
Other Intervention Name(s)
TOF-Watch
Intervention Description
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
Primary Outcome Measure Information:
Title
Emergence delirium in PACU
Description
Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale
Time Frame
up to 30 min
Secondary Outcome Measure Information:
Title
Emergence delirium severity, assessed in PACU
Description
Watcha score
Time Frame
up to 30 min
Title
Extubation time
Description
time interval between discontinuation of anesthetics and extubation
Time Frame
up to15 min
Title
Heart rate
Description
monitored intraoperatively ECG
Time Frame
up to 45 min
Title
Blood pressure
Description
monitored intraoperatively NIBP
Time Frame
up to 45 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelia Kalliardou, Consultant
Organizational Affiliation
Director of the Anesthesiology Dept.
Official's Role
Study Director
Facility Information:
Facility Name
Childrens Hospital P. and A. Kyriakou Anesthesiology Department
City
Athens
ZIP/Postal Code
11526
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

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