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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06601036
Enrollment
70
Registered
2024-09-19
Start date
2024-09-17
Completion date
2025-02-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake Fiberoptic Intubation, Difficult Airway, Sedation, Sevoflurane

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.

Interventions

DRUGSevoflurane

Patients will undergo fiberoptic intubation under sevoflurane sedation.

DRUG2% Xylocaine (2 ml )

Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of patient satisfactionImmediately after intubationThe 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

MeasureTime frameDescription
Intubation timeIntraoperativelyIntubation time (time from insertion of the fiberoptic bronchoscope throughout the nose till confirmation of intubation with capnography)
Heart rate5 minutes after intubationHeart 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 intubationMean 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 endoscopyIntraoperativelyThe 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 intubationIntraoperativelyThe 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)

Countries

Egypt

Contacts

Primary ContactMarwa A Abogabal, MD
Dr_mora1985@med.tanta.edu.eg00201004190210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026