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

Oman Medical Speciality Board

Status: Not yet enrolling

Conditions: Analgesia Assessment; Sedation

Treatments: Device: atomizer; Drug: Midazolam; Drug: Placabo; Drug: fentanyl; Drug: rescue medication; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07166666

MOH/ oman (Other Identifier)

MoH/CSR/24/28497

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 2 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

128 participants in 2 patient groups

midazolame $ fentanyl

Other group

Description:

use as compare between two group

Treatment:

Drug: rescue medication

Drug: fentanyl

Drug: Midazolam

Device: atomizer

dexetomidate

Other group

Description:

use as compare to other group

Treatment:

Drug: Dexmedetomidine

Drug: rescue medication

Drug: Placabo

Device: atomizer