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Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients

Not Applicable
Recruiting
Conditions
Sevoflurane
Sedation
Awake Fiberoptic Intubation
Difficult Airway
Interventions
Drug: 2% Xylocaine (2 ml )
Registration Number
NCT06601036
Lead Sponsor
Tanta University
Brief Summary

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

Detailed Description

Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.

For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria
  • 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).
Exclusion Criteria
  • Patient refusal.
  • Patients with bleeding disorders and nasal mass.
  • Allergy or intolerance to one of the study medications.
  • Patients with uncontrolled systemic diseases.
  • patients with gastro-esophageal reflex.
  • history of nasopharyngeal surgery or drug abuse.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Awake fiberoptic group2% Xylocaine (2 ml )Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.
Sevoflurane sedation groupSevofluranePatients will undergo fiberoptic intubation under sevoflurane sedation.
Primary Outcome Measures
NameTimeMethod
Degree of patient satisfactionImmediately after intubation

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).

Secondary Outcome Measures
NameTimeMethod
Intubation timeIntraoperatively

Intubation time (time from insertion of the fiberoptic bronchoscope throughout the nose till confirmation of intubation with capnography)

Heart rate5 minutes after intubation

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.

Mean arterial pressure5 minutes after intubation

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.

Patient's tolerance to endoscopyIntraoperatively

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).

Patient's tolerance to intubationIntraoperatively

The patient's reaction to the placement of the endotracheal tube will be assessed on a scale of 1 to 5 and was recorded (1, no reaction; 2, slight grimacing; 3, severe grimacing; 4, verbal objection; 5, defensive movement of head, hands, or feet)

Trial Locations

Locations (1)

Tanta University

🇪🇬

Tanta, El-Gharbia, Egypt

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