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出境医 / 临床实验 / Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine

Study Description
Brief Summary:
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.

Condition or disease Intervention/treatment Phase
Abdominal Cancer Drug: nebulized Dexmedetomidine Phase 1 Phase 2

Detailed Description:
Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: nebulized dexmedetomidine 2ug/kg
inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
Drug: nebulized Dexmedetomidine
inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min
Other Name: pharmacokinitics of nebulized dexmedetomidine

Active Comparator: nebulized dexmedetomidine 3ug/kg
inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
Drug: nebulized Dexmedetomidine
inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min
Other Name: pharmacokinitics of nebulized dexmedetomidine

Outcome Measures
Primary Outcome Measures :
  1. pharmacokinitics of dexmedetomidine [ Time Frame: at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes ]
    serum level of dexmedetomidine


Secondary Outcome Measures :
  1. sedation score [ Time Frame: baseline and after end of the drug adminstration by 30 mininute ]

    Ramsy sedation score

    1 = Anxious or restless or both Unacceptable; increase sedation 2=Cooperative, orientated and tranquil Acceptable; no action necessary 3=Responding to commands Acceptable; no action necessary 4=Brisk response to stimulus Acceptable; no action necessary 5=Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6= No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3



Eligibility Criteria
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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child aged 2-7 years
  • ASA I or II
  • scheduled for abdominal surgery
  • with average weight, height, normal serum albumin

Exclusion Criteria:

  • patients with allergy to the study drug
  • patients with significant organ dysfunction
  • patients with cardiac arrhythmia
  • patients with congenital heart disease
  • use of psychotropic medication and mental retardation.
Contacts and Locations

Contacts
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Contact: Shereen M Kamal, Lecturer +201006279209 sheridouh79@yahoo.com
Contact: Hala S Abdelgafar, Profesor +201003812011 hallasaad@yahoo.com

Locations
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Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 11715
Contact: Shereen M Kamal, Lecturer    01006279209    sheridouh79@yahoo.com   
Contact: Hala S Abdelgafar, Professor    01003812011    hallasaad@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Shereen M Kamal, Lecturer Ministry of higher education
Tracking Information
First Submitted Date  ICMJE November 29, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
pharmacokinitics of dexmedetomidine [ Time Frame: at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes ]
serum level of dexmedetomidine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
sedation score [ Time Frame: baseline and after end of the drug adminstration by 30 mininute ]
Ramsy sedation score 1 = Anxious or restless or both Unacceptable; increase sedation 2=Cooperative, orientated and tranquil Acceptable; no action necessary 3=Responding to commands Acceptable; no action necessary 4=Brisk response to stimulus Acceptable; no action necessary 5=Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6= No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine
Official Title  ICMJE Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
Brief Summary the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.
Detailed Description Inhalation of nebulized drug is an alternative route of administration that is relatively easy to set up, does not require venpuncture, but is associated with high bioavailability of the administered drug. Information on the pharmacokinetics of dexmedetomidine in the pediatric population is very limited, especially in children. To the best of investigators knowledge, there are no published reports on the pharmacokinetics of nebulized dexmedetomidine in children.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Abdominal Cancer
Intervention  ICMJE Drug: nebulized Dexmedetomidine
inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min
Other Name: pharmacokinitics of nebulized dexmedetomidine
Study Arms  ICMJE
  • Active Comparator: nebulized dexmedetomidine 2ug/kg
    inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
    Intervention: Drug: nebulized Dexmedetomidine
  • Active Comparator: nebulized dexmedetomidine 3ug/kg
    inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
    Intervention: Drug: nebulized Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • child aged 2-7 years
  • ASA I or II
  • scheduled for abdominal surgery
  • with average weight, height, normal serum albumin

Exclusion Criteria:

  • patients with allergy to the study drug
  • patients with significant organ dysfunction
  • patients with cardiac arrhythmia
  • patients with congenital heart disease
  • use of psychotropic medication and mental retardation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762785
Other Study ID Numbers  ICMJE 435
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shereen Mamdouh, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shereen M Kamal, Lecturer Ministry of higher education
PRS Account Assiut University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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