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

Phase 4

Completed

• Conditions: Awake Fiberoptic Intubation
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine plus Midazolam

• Registration Number: NCT06946212
• Lead Sponsor: Zagazig University

Brief 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 .

Study Timeline

• Study Start: 2023-05-15
• Primary Completion: 2024-01-20
• Study Completion: 2024-04-04
• Status Verified: 2025-04
• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patient consent
• Age 21 to 60 years
• Both male and female
• ASA I and ASA II
• BMI : ((18.5 - 35 kg/ m2 )),
• Patient scheduled to undergo elective surgeries under general anesthesia.
• Patient with suspected difficult airway.

Exclusion Criteria

• Sever chronic disease (cardiovascular, respiratory, renal and hepatic).
• Coagulopathies
• Mental retarted or psychiatric disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Dexmedetomidine	patients will receive 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
ketamine with midazolam Group	Ketamine plus Midazolam	patients will receive 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

Primary Outcome Measures

Name	Time	Method
Patient tolerance	During the procedure of awake fiberoptic intubation	Patient tolerance assessed by independent observer by a five-point fiberoptic intubation comfort score (1 = no reaction, 2 = slight grimacing, 3 = heavy grimacing, 4 = verbal objection, 5 = defensive movement of head and hands

Secondary Outcome Measures

Name	Time	Method
Intubation score	During the procedure of awake fiberoptic intubation	Intubation score was assessed by vocal cord movement (1 = open, 2 = moving, 3 = closing, 4 = closed) and coughing (1 = none, 2 = one gag or cough only, 3 = \>1 gag or cough, but acceptable conditions, 4 = unacceptable conditions)

Trial Locations

Locations (1)

Faculty of Medicine Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt