Abdominal CancerPhase 1/2NCT03762785
Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine
A Phase 1/2 study testing nebulized Dexmedetomidine in people with Abdominal Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- nebulized Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2018to Jan 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child aged 2-7 years
- ASA I or II
- scheduled for abdominal surgery
- with average weight, height, normal serum albumin
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 11715
Shereen M Kamal, Lecturer, 01006279209, sheridouh79@yahoo.com
Hala S Abdelgafar, Professor, 01003812011, hallasaad@yahoo.com
About this study
Official title: Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
the aim of this study is to study the pharmacokinetics and dynamics of nebulized dexmetedomidine in children undergoing major abdominal cancer surgery.
Read the 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.
- Conditions
- Abdominal Cancer
- Being tested
- nebulized Dexmedetomidine
- Keywords
- pharmacokinitics, nebulized, dexmedetomidine, preschool children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized DexmedetomidineDrug
Also called pharmacokinitics of 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
| Study group | Role | What they receive |
|---|---|---|
| nebulized dexmedetomidine 2ug/kg | Active comparator | inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization Receives: Drug: nebulized Dexmedetomidine |
| nebulized dexmedetomidine 3ug/kg | Active comparator | inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization Receives: Drug: nebulized Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinitics of dexmedetomidine
serum level of dexmedetomidine
Measured: 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
Secondary outcomes (1)
sedation score
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
Measured: baseline and after end of the drug adminstration by 30 mininute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start10 Dec 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
- Investigators
- Shereen M Kamal, Lecturer, Principal investigator, Ministry of higher education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762785
- Sponsor's protocol ID
- 435
- Status last verified
- Jan 2019
- First submitted
- 29 Nov 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03762785
- Acronym / sponsor ID
- 435
- Conditions
- Abdominal Cancer
- Keywords
- pharmacokinitics, nebulized, dexmedetomidine, preschool children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nebulized dexmedetomidine 2ug/kg | Active comparator | Drug: nebulized Dexmedetomidineinhalation of dexmedetomidine in the dose of 2ug/kg by nebulization |
| nebulized dexmedetomidine 3ug/kg | Active comparator | Drug: nebulized Dexmedetomidineinhalation of dexmedetomidine in the dose of 3ug/kg by nebulization |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child aged 2-7 years
- ASA I or II
- scheduled for abdominal surgery
- with average weight, height, normal serum albumin
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nebulized DexmedetomidineAlso: pharmacokinitics of nebulized dexmedetomidineinhalation 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 | Drug | nebulized dexmedetomidine 2ug/kg, nebulized dexmedetomidine 3ug/kg |
Primary outcome
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
1 secondary outcome
sedation score
Time frame: baseline and after end of the drug adminstration by 30 mininute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen M Kamal, Lecturer principal investigator
Ministry of higher education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nebulized Dexmedetomidine in people with Abdominal Cancer, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shereen M Kamal, Lecturer (+201006279209, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.