Condition or disease | Intervention/treatment | Phase |
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Abdominal Cancer | Drug: nebulized Dexmedetomidine | Phase 1 Phase 2 |
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 |
Arm | Intervention/treatment |
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Active Comparator: nebulized dexmedetomidine 2ug/kg
inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
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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
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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
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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
Ages Eligible for Study: | 3 Years to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shereen M Kamal, Lecturer | +201006279209 | sheridouh79@yahoo.com | |
Contact: Hala S Abdelgafar, Profesor | +201003812011 | hallasaad@yahoo.com |
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 |
Principal Investigator: | Shereen M Kamal, Lecturer | Ministry of higher education |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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
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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 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Prevention |
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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
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Shereen Mamdouh, Assiut University | ||||
Study Sponsor ICMJE | Assiut University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |