Clinical trial NCT06946212: Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation in Suspected Difficult Airway
Official title: Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation With Topical Anesthesia in Suspected Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Awake Fiberoptic Intubation
Keywords: Sedation
Awake fiberoptic intubation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-04-27
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Patient tolerance
timeFrame: During the procedure of awake fiberoptic intubation
Secondary outcomes:
measure: Intubation score
timeFrame: During the procedure of awake fiberoptic intubation
Other outcomes:
measure: Intubation time
timeFrame: from introduction of fibroscope till endotracheal tube in place confirmed.
measure: Mean arterial blood pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Oxygen saturation
timeFrame: 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
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine Zagazig University
state: Sharkia
Study officials:
References: