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Completed

NCT Number: NCT07069686

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

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

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt, 11111

About this study

A.Preoperative settings:

A thorough preoperative evaluation including a complete airway evaluation (mouth opening, mallampati grading, body weight, thyromental distance, and evaluation of dentition) will be performed. Standard fasting guidelines and anti-aspiration prophylaxis with tablet ranitidine 150 mg will be prescribed.

The patients will be explained about the awake C-MAC intubation during preoperative assessment.Injection of atropine 0.4 mg will be given half an hour before shifting the patient to the operating room (OR).

B.Intraoperative and postoperative settings:

Injection of atropine 0.4 mg will be given half an hour before shifting the patient to the operating room (OR). Inside the OR, standard monitoring, including electrocardiography (ECG), noninvasive blood pressure (BP), and pulse oximetry (SpO2) will be applied in all patients. An intravenous (IV) line will be secured and ringer lactate will be started. After recording the baseline heart rate (HR), BP and SpO2, Injection of Dexametomidate 0.7 mcg/kg/hr IV infusion and injection ketamine 0.5-2 mg/kg slow IV single dose until endotracheal tube secured.

For each group, local anesthetics will be given in first group (LA)guided by ultrasound and second group (T) with topical method until Adequate effect of local anesthesia confirmed by hoarseness of voice in Group LA patients and numbness of tongue in Group T patients. While giving supplemental oxygen through nasal prongs, C-MAC intubation will be performed. After the airway is secured, general anesthesia will be administered with propofol 2 mg/kg, and rocuronium 0.6 mg/kg.

Postoperatively, patient comfort will be assessed for sore throat, dysphagia, voice change, or any lip, gum, tongue, dental injuries, complete amnesia, partial recall, and unpleasant memories during awake C-MAC intubation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

lidocaine topical anesthesia for Endotracheal intubation

Procedure

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

Primary outcomes

  1. Incidence of Gag reflex and cough reflex

    Time frame: After applying local anesthesia by at least 3 minutes

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

Secondary outcomes

  1. Mean blood pressure (MAP)

    Time frame: After applying local anesthesia by at least 3 minutes

    After taking local anesthesia monitoring of Mean blood pressure (MAP) will be monitored during the process of endotracheal intubation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound-Guided Airway Nerve Blocks vs. Lidocaine Topical Anesthesia Using Video-Assisted Laryngoscopy in Suspected Difficult Intubation for Patients Undergoing Bariatric Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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