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

Zagazig University34 enrolled

Overview

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?

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Awake Fiberoptic Intubation

Interventions

DexmedetomidineDRUG

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 plus MidazolamDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine Zagazig University

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

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

Time frame: During the procedure of awake fiberoptic intubation

Secondary Outcomes

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)

Time frame: During the procedure of awake fiberoptic intubation

Data from ClinicalTrials.gov

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