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

NCT ID: NCT06946212

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-04-04

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 .

Conditions

Awake Fiberoptic Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

dexmedetomidine group

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

ketamine with midazolam Group

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

Group Type: ACTIVE_COMPARATOR

Ketamine plus Midazolam

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Salwa Samir El Sherbeny

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Zagazig University

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

Zu-IRB 10831-28/5-2023

Identifier Type: -

Identifier Source: org_study_id