NCT06946212

Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation in Suspected Difficult Airway

Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation With Topical Anesthesia in Suspected Difficult Airway

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to obtain the optimal patient's comfort and cooperation during awake fiberoptic intubation with prototype device. The main question it aims to answer is: Which drug provides better sedative effect during awake fiberoptic intubation, dexmedetomidine or ketamine- midazolam combination with prototype supraglottic topical anaesthesia device?

Detailed description

Awake fiberoptic intubation is the gold standard technique for managing patients with anticipated difficult airway. Conscious sedation and topical anesthesia is desirable, not only to make the procedure more tolerable and comfortable for the patient but also to ensure optimal intubating conditions. Ideal Topical Anesthesia and sedation regime for Awake fiberoptic intubation should provide comfort, cooperation, hemodynamic stability along with maintenance of spontaneous respiration. Several sedative agents have been assessed in previous studies) for this purpose (like benzodiazepine ,opioids ,ketamine , propofol and dexmedetomidine So it is important to know which has the best sedative effect dexmedetomidine or ketamine - midazolam combination with undisturbed respiratory function .

Conditions

• Awake Fiberoptic Intubation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	In Dexmedetomidine group: patients received an intravenous dose of dexmedetomidine at 1 mcg/kg over 10 min in 100 mL normal saline followed by continous infusion of dexmedetomidine at 0.2mcg/kg/h up to 0.7mcg/kg/hr till reaching Ramsay sedation score 2-3
DRUG	Ketamine plus Midazolam	In Ketamine Midazolam group: patients received midazolam 0.02 mg /kg IV then 2 minutes later take ketamine 0.25 mg/kg IV and we will repeated this mixture till reaching Ramsay sedation score 2-3

Timeline

• Start date: 2023-05-15
• Primary completion: 2024-01-20
• Completion: 2024-04-04
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: Egypt