SedationNCT07166666
Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)
A study testing atomizer, rescue medication and Midazolam in people with Sedation and Analgesia Assessment, run by Oman Medical Speciality Board at 1 site in Oman.
Trial summary
To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam \& Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Sedation, Analgesia Assessment
- What is being tested?
- atomizer, rescue medication and Midazolam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteOman
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 2 to 60 years.
- Patients undergoing EM procedures requiring sedation.
Who cannot join
- Patients with contraindications to any of the sedation agents being studied.
- Patients with a history of adverse reactions or allergies to the study medications.
- Drug interactions: Patients taking certain medications that may interact adversely with the study medications.
- Drug Abuser
- Pregnancy and breastfeeding
- Patients with significant cardiovascular or respiratory compromise.
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- Patients with nasal disorder (nasal trauma, epistaxis)
- Patients unable to provide informed consent or those with cognitive impairment.
- Patients who are < 2 year of age or > 60 year of age.
- Patient underwent procedure sedation for imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam \& Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities.
- Conditions
- Sedation, Analgesia Assessment
- Being tested
- atomizer, rescue medication, Midazolam, fentanyl, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atomizerDevice
use atomizer to provide the medication in procedure sedation
rescue medicationDrug
will be used as rescue if the atomizer medication not fully sedated
MidazolamDrug
Intranasal administration for procedural sedation.
fentanylDrug
Intranasal administration for procedural sedation.
DexmedetomidineDrug
Intranasal administration for procedural sedation.
PlacaboDrug
use atomizer to provide the placebo in procedure sedation
| Study group | Role | What they receive |
|---|---|---|
| midazolame $ fentanyl | Other | use as compare between two group Receives: Device: atomizer; Drug: rescue medication; Drug: Midazolam; Drug: fentanyl |
| dexetomidate | Other | use as compare to other group Receives: Device: atomizer; Drug: rescue medication; Drug: Dexmedetomidine; Drug: Placabo |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of sedtion
using MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ghaliya Al Noofli, Oman Medical Speciality Board
- Investigators
- saud al bulashi, MD, Study director, MOH/ oman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166666
- Sponsor's protocol ID
- MoH/CSR/24/28497
- Other IDs
- MOH/ oman
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)
- ClinicalTrials.gov ID
- NCT07166666
- Acronym / sponsor ID
- MoH/CSR/24/28497
- Conditions
- Sedation, Analgesia Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Sep 2025 (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.
To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam \& Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolame $ fentanyl | Other | Device: atomizer, Drug: rescue medication, Drug: Midazolam, Drug: fentanyluse as compare between two group |
| dexetomidate | Other | Device: atomizer, Drug: rescue medication, Drug: Dexmedetomidine, Drug: Placabouse as compare to other group |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (10 listed)
- Patients with contraindications to any of the sedation agents being studied.
- Patients with a history of adverse reactions or allergies to the study medications.
- Drug interactions: Patients taking certain medications that may interact adversely with the study medications.
- Drug Abuser
- Pregnancy and breastfeeding
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 |
|---|---|---|
| atomizeruse atomizer to provide the medication in procedure sedation | Device | dexetomidate, midazolame $ fentanyl |
| rescue medicationwill be used as rescue if the atomizer medication not fully sedated | Drug | dexetomidate, midazolame $ fentanyl |
| MidazolamIntranasal administration for procedural sedation. | Drug | midazolame $ fentanyl |
| fentanylIntranasal administration for procedural sedation. | Drug | midazolame $ fentanyl |
| DexmedetomidineIntranasal administration for procedural sedation. | Drug | dexetomidate |
| Placabouse atomizer to provide the placebo in procedure sedation | Drug | dexetomidate |
Primary outcome
depth of sedtion
Time frame: 1 year
using MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
saud al bulashi, MD study director
MOH/ oman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atomizer, rescue medication and Midazolam in people with Sedation and Analgesia Assessment, run by Oman Medical Speciality Board at 1 site in Oman.
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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Sep 2025. 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 Oman. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghaliy khamis al noofli, MD (+96895751564, r23029@resident.omsb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of sedtion (time frame: 1 year). 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 Sep 2025.