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

NCT06601036 | Recruiting

• 1 other identifier: 36264PR591/3/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Sevoflurane; Sedation; Awake Fiberoptic Intubation; Difficult Airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intubation time

  Intraoperatively

• Heart rate

  5 minutes after intubation

• Mean arterial pressure

  5 minutes after intubation

• Patient's tolerance to endoscopy

  Intraoperatively

• Patient's tolerance to intubation

  Intraoperatively

Study Arms (2)

Sevoflurane sedation group

EXPERIMENTAL

Patients will undergo fiberoptic intubation under sevoflurane sedation.

Drug: Sevoflurane

Awake fiberoptic group

ACTIVE COMPARATOR

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

Drug: 2% Xylocaine (2 ml )

Interventions

Sevoflurane DRUG

Patients will undergo fiberoptic intubation under sevoflurane sedation.

Sevoflurane sedation group

2% Xylocaine (2 ml ) DRUG

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

Awake fiberoptic group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Sevoflurane; Lidocaine

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Marwa A Abogabal, MD

CONTACT

00201004190210; Dr_mora1985@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Intensive Care and Pain, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: September 17, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)