ClinicalTrials.gg
Not yet recruitingNCT07166666Updated Sep 10, 2025

Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)

An interventional study of atomizer and rescue medication in Sedation and Analgesia Assessment, sponsored by Oman Medical Speciality Board. Not yet recruiting at 1 site in Oman. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Oman Medical Speciality Board · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
2 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sedation
  • Analgesia Assessment
03

In context

Lead sponsor

Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • inclusion criteria:

    1. Patients aged 2 to 60 years.
    2. Patients undergoing EM procedures requiring sedation.

Exclusion criteria:

  1. Patients with to any of the sedation agents being studied.
  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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
128 participants (estimated)

Study arms

  • Other
    midazolame $ fentanyl

    use as compare between two group

    Device: atomizer · Drug: rescue medication · Drug: Midazolam · Drug: fentanyl

  • Other
    dexetomidate

    use as compare to other group

    Device: atomizer · Drug: rescue medication · Drug: Dexmedetomidine · Drug: Placabo

Interventions

  • Deviceatomizer

    use atomizer to provide the medication in procedure sedation

  • Drugrescue medication

    will be used as rescue if the atomizer medication not fully sedated

  • Intranasal administration for procedural sedation.

  • Intranasal administration for procedural sedation.

  • Intranasal administration for procedural sedation.

  • DrugPlacabo

    use atomizer to provide the placebo in procedure sedation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

1 site
  • dr.Suad al baluish
    Muscat, Oman
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2025
First posted
Sep 10, 2025
StartEst.
Sep 1, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Oct 1, 2026
Last update
Sep 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07166666
Lead sponsor
Oman Medical Speciality Board
Responsible party
Ghaliya Al Noofli (Principal Investigator, Oman Medical Speciality Board) — Principal investigator
First posted
Sep 10, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Sep 10, 2025

Study contacts

Ghaliy khamis al noofli, MD
Contact
r23029@resident.omsb.org
+96895751564
ahoud abdullah al saidi, MD
Contact
r23031@resident.omsb.org
+96892903021
saud al bulashi, MD
study director · MOH/ oman

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Midazolam · Fentanyl · Dexmedetomidine

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