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

Not Applicable

Not yet recruiting

• Conditions: Sedation; Analgesia Assessment
• Interventions: Device: atomizer; Drug: rescue medication; Drug: Dexmedetomidine; Drug: Midazolam; Drug: fentanyl; Drug: Placabo

• Registration Number: NCT07166666
• Lead Sponsor: Oman Medical Speciality Board

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-23
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-09-30
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolame $ fentanyl	atomizer	use as compare between two group
midazolame $ fentanyl	rescue medication	use as compare between two group
dexetomidate	Dexmedetomidine	use as compare to other group
midazolame $ fentanyl	Midazolam	use as compare between two group
midazolame $ fentanyl	fentanyl	use as compare between two group
dexetomidate	atomizer	use as compare to other group
dexetomidate	rescue medication	use as compare to other group
dexetomidate	Placabo	use as compare to other group

Primary Outcome Measures

Name	Time	Method
depth of sedtion	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

Trial Locations

Locations (1)

dr.Suad al baluish; 🇴🇲 Muscat, Oman