US-guided Airway Nerve Block vs. Topical Lidocaine in Video Laryngoscopy for Difficult Bariatric Intubation.

NCT07069686 | Completed DMC

• 1 other identifier: FMASU MS 120/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the effects of ultrasound guided airway nerve block vs lidocaine topical anesthesia and it's direct effect in decreasing incidence of gag and cough reflex in suspected difficult intubation patients using video assisted laryngoscopey for those Undergoing bariatric surgery

Conditions

Gag Reflex

Outcome Measures

Primary Outcomes (1)

• Incidence of Gag reflex and cough reflex

  After taking local anesthesia monitoring of gag and cough reflexes will be monitored during the process of endotracheal intubation

  After applying local anesthesia by at least 3 minutes

Secondary Outcomes (1)

• Mean blood pressure (MAP)

  After applying local anesthesia by at least 3 minutes

Study Arms (2)

Group LA

ACTIVE COMPARATOR

patients will be intubated using the video-assisted laryngoscope after taking airway nerves block guided by ultrasound device

Procedure: Ultrasound guided airway nerve block for Endotracheal intubation

Group T

ACTIVE COMPARATOR

patients will be intubated using the video-assisted laryngoscope after topical lidocaine 10% spraying as-you-go to oro-pharyngeo-laryngeal cavity without exceeding the toxic dose.

Procedure: lidocaine topical anesthesia for Endotracheal intubation

Interventions

Ultrasound guided airway nerve block for Endotracheal intubation PROCEDURE

Glossopharyngeal nerve block: 1.5 mL 2% lidocaine, ultrasound probe on lateral neck below mandible, landmark = hyoid bone, tilt cephalad to target pharyngeal wall near tonsil; right side needle inserted out-of-plane from superior probe edge to avoid artery. Bilateral superior laryngeal nerve blocks: out-of-plane at lateral thyroid cartilage, orient probe medially, inject 1 mL 2% lidocaine into thyrohyoid membrane between hyoid and thyroid cartilage using 25-G 25 mm needle. Bilateral recurrent laryngeal nerve blocks: translaryngeal out-of-plane, locate cricothyroid membrane below thyroid cartilage, insert 25-G 25 mm needle 1.5 cm, confirm air backflow, inject 2 mL 2% lidocaine.

Group LA

lidocaine topical anesthesia for Endotracheal intubation PROCEDURE

will receive topical lidocaine 10% spray directly on the tongue and oropharynx without exceeding toxic doses.

Group T

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 21-65 years old
• Obese patients (BMI\>35 kg/m2) undergoing bariatric surgery
• Suspected difficult intubation: e.g:(Mallampati score ≥3 , Thyromental distance \<6 cm, Limited neck mobility, History of difficult intubation)
• ASA I-II

You may not qualify if:

• Patients at increased risk for aspiration (e.g., full stomach or gastro-esophageal reflux disease) and pregnancy
• Patients with expected difficult ventilation
• Patients who have upper airway pathology or surgery
• Patients with a mouth opening \< 2 cm
• ASA III-IV
• Emergency surgery
• Allergy to local anesthetics
• Contraindication to nerve blocks e.g.:(Coagulopathy, Infection at site of injection)
• Patient refusal
• Neurological or cognitive impairment making the patient uncooperative
• History of difficult airway complications e.g.: previous intubation failure or need for surgical airway
• Cervical spine instability or fractures

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Conditions

Gagging

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• David B Nabih, M.B.B.CH

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 17, 2025
• Study Start: February 20, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)