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

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?

Study Overview

• Status: Completed
• Conditions: Awake Fiberoptic Intubation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketamine plus Midazolam

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44511
      • Faculty of Medicine Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient tolerance	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	During the procedure of awake fiberoptic intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation score	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)	During the procedure of awake fiberoptic intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Intubation time: from introduction of fibroscope till endotracheal tube in place confirmed.	from introduction of fibroscope till endotracheal tube in place confirmed.
Mean arterial blood pressure	Mean arterial blood pressure ( MAP Measured in mmHg) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation).	at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation
Heart rate	Heart rate ( HR Measured in beat/ minute) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation).	Heart rate assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation
Oxygen saturation	Oxygen saturation ( spO2 Measured in percentage) which assessed at five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation).	At five different times (baseline, 2 min after sedation, at the beginning of fiberscopy as it passes through the nostril, after advancing the ETT through the nasopharynx and 2 min after endotracheal intubation

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Sedation; Awake fiberoptic intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Midazolam; Dexmedetomidine; Ketamine
• Other Study ID Numbers: Zu-IRB 10831-28/5-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes