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

Study Overview

• Status: Recruiting
• Conditions: Sevoflurane; Sedation; Difficult Airway; Awake Fiberoptic Intubation
• Intervention / Treatment: Drug: Sevoflurane; Drug: 2% Xylocaine (2 ml )

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa A Abogabal, MD; Phone Number: 00201004190210; Email: Dr_mora1985@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Marwa A Abogabal, MD; Phone Number: 00201004190210; Email: Dr_mora1985@med.tanta.edu.eg
      • Principal Investigator: Mohamed Z Wfa, MD
      • Principal Investigator: Laila A El-Ahwal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sevoflurane sedation group; Patients will undergo fiberoptic intubation under sevoflurane sedation.	Drug: Sevoflurane; Patients will undergo fiberoptic intubation under sevoflurane sedation.
Active Comparator: Awake fiberoptic group; Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.	Drug: 2% Xylocaine (2 ml ); Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	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).	Immediately after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Intubation time (time from insertion of the fiberoptic bronchoscope throughout the nose till confirmation of intubation with capnography)	Intraoperatively
Heart rate	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.	5 minutes after intubation
Mean arterial pressure	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.	5 minutes after intubation
Patient's tolerance to endoscopy	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).	Intraoperatively
Patient's tolerance to intubation	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)	Intraoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Inhalation; Lidocaine; Sevoflurane
• Other Study ID Numbers: 36264PR591/3/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No