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

Zagazig University

Status and phase: Completed; Phase 4

Conditions: Awake Fiberoptic Intubation

Treatments: Drug: Dexmedetomidine; Drug: Ketamine plus Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06946212

Zu-IRB 10831-28/5-2023

Details and patient eligibility

About

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?

Full 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 .

Enrollment: 34 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

dexmedetomidine group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

ketamine with midazolam Group

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine plus Midazolam