Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06601036

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

Led by Tanta University · Updated on 2024-09-19

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare patient satisfaction and intubating conditions during fiberoptic intubation performed under two different methods for patients with difficult airways. The study focuses on adults ages 18 to 50 who have anticipated difficult intubation due to airway anatomy or pathology. Awake fiberoptic intubation (AFOI) usually requires a calm and cooperative patient with reduced airway reflexes, and sedative or anxiolytic agents are used to help achieve comfort without affecting breathing. Participants will be randomly assigned to one of two groups. One group will have fiberoptic intubation under sevoflurane sedation, while the other will receive bilateral Superior Laryngeal Nerve blocks and Recurrent Laryngeal nerve blocks with 2% Xylocaine before intubation. Both approaches are intended to facilitate the procedure in difficult airway cases, and the trial compares these methods for patient comfort and procedural conditions. During the study, several measures will be taken including patient satisfaction immediately after intubation, intubation time, heart rate, mean arterial pressure, and patient tolerance to endoscopy and intubation. These assessments will happen during and shortly after the procedure to evaluate the experience and physiological responses. The entire process involves careful monitoring to assess the safety and comfort of both approaches in this patient group.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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 reflux
  • History of nasopharyngeal surgery or drug abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of intubation

Participants receive fiberoptic intubation under sedation or nerve block as part of the study procedure.

1 visit (in-person)

Follow-up

Duration - Up to 5 minutes after intubation

Participants are monitored immediately and within minutes after intubation for satisfaction and vital signs.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Tanta University

Tanta, El-Gharbia, Egypt, 31527

Actively Recruiting

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Research Team

M

Marwa A Abogabal, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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