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Clinical Trials/NCT07069686
NCT07069686CompletedNot Applicable

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

Ain Shams University1 site in 1 country80 target enrollmentStarted: February 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Incidence of Gag reflex and cough reflex

Study Overview

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

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
  • •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

Arms & Interventions

Group LA

Active Comparator

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

Intervention: Ultrasound guided airway nerve block for Endotracheal intubation (Procedure)

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.

Intervention: lidocaine topical anesthesia for Endotracheal intubation (Procedure)

Outcomes

Primary Outcomes

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

  • Mean blood pressure (MAP)(After applying local anesthesia by at least 3 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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