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

NCT07166666 | Not Yet Recruiting DMC

• 2 other identifiers: MoH/CSR/24/28497MOH/ oman
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Analgesia Assessment

Outcome Measures

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

  1 year

Study Arms (2)

midazolame $ fentanyl

OTHER

use as compare between two group

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

dexetomidate

OTHER

use as compare to other group

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

Interventions

atomizer DEVICE

use atomizer to provide the medication in procedure sedation

dexetomidate; midazolame $ fentanyl

rescue medication DRUG

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

dexetomidate; midazolame $ fentanyl

Midazolam DRUG

Intranasal administration for procedural sedation.

midazolame $ fentanyl

fentanyl DRUG

Intranasal administration for procedural sedation.

midazolame $ fentanyl

Dexmedetomidine DRUG

Intranasal administration for procedural sedation.

dexetomidate

Placabo DRUG

use atomizer to provide the placebo in procedure sedation

dexetomidate

Eligibility Criteria

• Age: 2 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

dr.Suad al baluish

Muscat, Oman

Location

MeSH Terms

Interventions

Nebulizers and Vaporizers; Midazolam; Fentanyl; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles

Study Officials

• saud al bulashi, MD

  MOH/ oman

  STUDY DIRECTOR

Central Study Contacts

Ghaliy khamis al noofli, MD

CONTACT

+96895751564; r23029@resident.omsb.org

ahoud abdullah al saidi, MD

CONTACT

+96892903021; r23031@resident.omsb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

OM (1)