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NCT Number: NCT07166666

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

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.

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Key information

Conditions

Sedation Analgesia Assessment

Age range

2 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

dr.Suad al baluish

Muscat, Oman

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

atomizer

Device

use atomizer to provide the medication in procedure sedation

Rescue medication

Drug

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

midazolam

Drug

Intranasal administration for procedural sedation.

Fentanyl

Drug

Intranasal administration for procedural sedation.

Dexmedetomidine

Drug

Intranasal administration for procedural sedation.

Placabo

Drug

use atomizer to provide the placebo in procedure sedation

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ghaliy khamis al noofli, MD

CONTACT

[email protected]

+96895751564

ahoud abdullah al saidi, MD

CONTACT

[email protected]

+96892903021

Sponsors and collaborators

Lead sponsor

Oman Medical Speciality Board

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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