Craniofacial AbnormalitiesPhase 2NCT04426552
Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation
A Phase 2 study testing dexmedetomidine and sevoflurane in people with Craniofacial Abnormalities and Mandibular Hypoplasia, run by Alexandria University at 1 site in Egypt.
Trial summary
difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Craniofacial Abnormalities, Mandibular Hypoplasia
- What is being tested?
- dexmedetomidine and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 20 Oct 2020
- Phase
- Phase 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I and II
- aged 1 year to 3 years
- require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway
Who cannot join
- parents refusal
- Allergy to drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab Abd Elraof Abd Elaziz
Alexandria, Smouha, 000000
Rehab A. Abd Elaziz, Ass. Prof., 01001073703 ext. 020, trcium2002@yahoo.com
About this study
Official title: Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation
difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses
Read the detailed description
Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation
- Conditions
- Craniofacial Abnormalities, Mandibular Hypoplasia
- Being tested
- dexmedetomidine, sevoflurane
- Medical subject headings
- Craniofacial Abnormalities, Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
will have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
sevofluraneDrug
preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI Receives: Drug: dexmedetomidine |
| Sevoflurane | Active comparator | (sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intubation
as assessed by vocal cord movement
Measured: At intubation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion20 Sep 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial AbnormalitiesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
- Investigators
- Rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426552
- Sponsor's protocol ID
- 0304285
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation
- ClinicalTrials.gov ID
- NCT04426552
- Acronym / sponsor ID
- 0304285
- Conditions
- Craniofacial Abnormalities, Mandibular Hypoplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses
Detailed description
Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. The aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: dexmedetomidinehave a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI |
| Sevoflurane | Active comparator | Drug: sevoflurane(sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I and II
- aged 1 year to 3 years
- require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway
Key exclusion criteria (2 listed)
- parents refusal
- Allergy to drugs
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 |
|---|---|---|
| dexmedetomidinewill have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI | Drug | Dexmedetomidine |
| sevofluranepreoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation | Drug | Sevoflurane |
Primary outcome
Assessment of intubation
Time frame: At intubation time
as assessed by vocal cord movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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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.
Rehab A. Abd Elaziz, Ass.Prof. principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexmedetomidine and sevoflurane in people with Craniofacial Abnormalities and Mandibular Hypoplasia, run by Alexandria 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 3 inclusion and 2 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 12 Jun 2020. 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 phase mean?
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 Rehab A. Abd Elaziz, Ass. Prof. (01001073703 ext. 020, trcium2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of intubation (time frame: At intubation time). 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 12 Jun 2020.