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NCT Number: NCT06601036

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

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

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Key information

Conditions

Sevoflurane Awake Fiberoptic Intubation Difficult Airway Sedation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Laila A El-Ahwal, MD

PRINCIPAL_INVESTIGATOR

Marwa A Abogabal, MD

CONTACT

[email protected]

00201004190210

Mohamed Z Wfa, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevoflurane

Drug

Patients will undergo fiberoptic intubation under sevoflurane sedation.

2% Xylocaine (2 ml )

Drug

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

Primary outcomes

  1. Degree of patient satisfaction

    Time frame: Immediately 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 outcomes

  1. Intubation time

    Time frame: Intraoperatively

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

  2. Heart rate

    Time frame: 5 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.

  3. Mean arterial pressure

    Time frame: 5 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.

  4. Patient's tolerance to endoscopy

    Time frame: Intraoperatively

    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).

  5. Patient's tolerance to intubation

    Time frame: Intraoperatively

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa A Abogabal, MD

CONTACT

[email protected]

00201004190210

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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