Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorTanta University
About this trial
The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 50 years.
Both sexes.
American Society of Anesthesiology (ASA) physical status I-II.
Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).
Disqualifiers
Patient refusal.
Patients with bleeding disorders and nasal mass.
Allergy or intolerance to one of the study medications.
Patients with uncontrolled systemic diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Sevoflurane
DrugPatients will undergo fiberoptic intubation under sevoflurane sedation.
2% Xylocaine (2 ml )
DrugPatients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Sevoflurane sedation groupExperimental treatment 1 intervention
Group B: Awake fiberoptic groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 4-point Likert scale patient satisfaction (1, very dissatisfied; 2, unsatisfied; 3, satisfied; 4, very satisfied).
Time frame
Immediately after intubationSecondary outcomes
1
Intubation time
Intubation time (time from insertion of the fiberoptic bronchoscope throughout the nose till confirmation of intubation with capnography)
Time frame
Intraoperatively2
Heart rate
Heart rate will be recorded on arrival to the operating room as a baseline, immediately prior to fiberoptic intubation, at the time of intubation and then at 1, 3, and 5 minutes after intubation.
Time frame
5 minutes after intubation3
Mean arterial pressure
Mean arterial pressure will be recorded on arrival to the operating room as a baseline, immediately prior to fiberoptic intubation, at the time of intubation and then at 1, 3, and 5 minutes after intubation.
Time frame
5 minutes after intubation4
Patient's tolerance to endoscopy
The patient's reaction to the placement of the fiberoptic scope will be assessed on a scale of 1 to 5 and will be recorded (1, no reaction; 2, slight grimacing; 3, severe grimacing; 4, verbal objection; 5, defensive movement of head, hands, or feet).
Time frame
IntraoperativelySponsors and contacts
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Source ClinicalTrials.gov