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

NCT ID: NCT06601036

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-02-01

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.

Conditions

Sevoflurane; Sedation; Awake Fiberoptic Intubation; Difficult Airway

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevoflurane sedation group

Patients will undergo fiberoptic intubation under sevoflurane sedation.

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

Patients will undergo fiberoptic intubation under sevoflurane sedation.

Awake fiberoptic group

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

Group Type: ACTIVE_COMPARATOR

2% Xylocaine (2 ml )

Intervention Type: DRUG

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

Interventions

Sevoflurane

Patients will undergo fiberoptic intubation under sevoflurane sedation.

Intervention Type: DRUG

2% Xylocaine (2 ml )

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Ahmed Abogabal

Lecturer of Anesthesiology, Intensive Care and Pain, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa A Abogabal, MD

Role: CONTACT

Dr_mora1985@med.tanta.edu.eg

00201004190210

Facility Contacts

Marwa A Abogabal, MD

Role: primary

Dr_mora1985@med.tanta.edu.eg

00201004190210

Other Identifiers

36264PR591/3/24

Identifier Type: -

Identifier Source: org_study_id