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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07166666
Enrollment
128
Registered
2025-09-10
Start date
2025-09-01
Completion date
2026-10-01
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation, Analgesia Assessment

Brief 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.

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

DRUGMidazolam

Intranasal administration for procedural sedation.

DRUGfentanyl

Intranasal administration for procedural sedation.

DRUGDexmedetomidine

Intranasal administration for procedural sedation.

DRUGPlacabo

use atomizer to provide the placebo in procedure sedation

Sponsors

Oman Medical Speciality Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* inclusion criteria: 1. Patients aged 2 to 60 years. 2. Patients undergoing EM procedures requiring sedation.

Exclusion criteria

1. Patients with contraindications 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 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

Design outcomes

Primary

MeasureTime frameDescription
depth of sedtion1 yearusing MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation

Countries

Oman

Contacts

Primary ContactGhaliy khamis al noofli, MD
r23029@resident.omsb.org+96895751564
Backup Contactahoud abdullah al saidi, MD
r23031@resident.omsb.org+96892903021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026