Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)
NCT ID: NCT07166666
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
128 participants
INTERVENTIONAL
2025-09-01
2026-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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midazolame $ fentanyl
use as compare between two group
atomizer
use atomizer to provide the medication in procedure sedation
rescue medication
will be used as rescue if the atomizer medication not fully sedated
Midazolam
Intranasal administration for procedural sedation.
fentanyl
Intranasal administration for procedural sedation.
dexetomidate
use as compare to other group
atomizer
use atomizer to provide the medication in procedure sedation
rescue medication
will be used as rescue if the atomizer medication not fully sedated
Dexmedetomidine
Intranasal administration for procedural sedation.
Placabo
use atomizer to provide the placebo in procedure sedation
Interventions
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atomizer
use atomizer to provide the medication in procedure sedation
rescue medication
will be used as rescue if the atomizer medication not fully sedated
Midazolam
Intranasal administration for procedural sedation.
fentanyl
Intranasal administration for procedural sedation.
Dexmedetomidine
Intranasal administration for procedural sedation.
Placabo
use atomizer to provide the placebo in procedure sedation
Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing EM procedures requiring sedation.
Exclusion Criteria
2. Patients with a history of adverse reactions or allergies to the study medications.
3. Drug interactions: Patients taking certain medications that may interact adversely with the study medications.
4. Drug Abuser
5. Pregnancy and breastfeeding
6. Patients with significant cardiovascular or respiratory compromise.
7. Patients with nasal disorder (nasal trauma, epistaxis)
8. Patients unable to provide informed consent or those with cognitive impairment.
9. Patients who are \< 2 year of age or \> 60 year of age.
10. Patient underwent procedure sedation for imaging
2 Years
60 Years
ALL
No
Sponsors
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Oman Medical Speciality Board
OTHER_GOV
Responsible Party
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Ghaliya Al Noofli
Principal Investigator
Principal Investigators
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saud al bulashi, MD
Role: STUDY_DIRECTOR
MOH/ oman
Locations
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dr.Suad al baluish
Muscat, , Oman
Countries
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Central Contacts
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Other Identifiers
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MOH/ oman
Identifier Type: OTHER
Identifier Source: secondary_id
MoH/CSR/24/28497
Identifier Type: -
Identifier Source: org_study_id
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