Gag ReflexNCT07069686
US-guided Airway Nerve Block vs. Topical Lidocaine in Video Laryngoscopy for Difficult Bariatric Intubation.
A study testing Ultrasound guided airway nerve block for Endotracheal intubation and lidocaine topical anesthesia for Endotracheal intubation in people with Gag Reflex, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gag Reflex
- What is being tested?
- Ultrasound guided airway nerve block for Endotracheal intubation and lidocaine topical anesthesia for Endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Airway Nerve Blocks vs. Lidocaine Topical Anesthesia Using Video-Assisted Laryngoscopy in Suspected Difficult Intubation for Patients Undergoing Bariatric Surgery
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
Read the 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.
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.
- Conditions
- Gag Reflex
- Being tested
- Ultrasound guided airway nerve block for Endotracheal intubation, lidocaine topical anesthesia for Endotracheal intubation
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided airway nerve block for Endotracheal intubationProcedure or surgery
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 intubationProcedure or surgery
will receive topical lidocaine 10% spray directly on the tongue and oropharynx without exceeding toxic doses.
| Study group | Role | What they receive |
|---|---|---|
| Group LA | Active comparator | patients will be intubated using the video-assisted laryngoscope after taking airway nerves block guided by ultrasound device Receives: 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. Receives: Procedure: lidocaine topical anesthesia for Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After applying local anesthesia by at least 3 minutes
Secondary outcomes (1)
Mean blood pressure (MAP)
After taking local anesthesia monitoring of Mean blood pressure (MAP) will be monitored during the process of endotracheal intubation
Measured: After applying local anesthesia by at least 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Feb 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gag ReflexStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B Nabih, M.B.B.CH, Principal investigator, Anesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069686
- Sponsor's protocol ID
- FMASU MS 120/2025
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Publications
Hashim RM, Zaki MSM, Elagiby DBN, Taher IAA. Ultrasound-Guided Airway Nerve Blocks vs. Lidocaine Topical Anesthesia Using Video-Assisted Laryngoscopy in Suspected Difficult Intubation for Patients Undergoing Bariatric Surgery: A Randomized Clinical Trial. Anesthesiol Res Pract. 2026 May 22;2026:2054379. doi: 10.1155/anrp/2054379. eCollection 2026.
PubMed 42180592
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Airway Nerve Blocks vs. Lidocaine Topical Anesthesia Using Video-Assisted Laryngoscopy in Suspected Difficult Intubation for Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07069686
- Acronym / sponsor ID
- FMASU MS 120/2025
- Conditions
- Gag Reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group LA | Active comparator | Procedure: Ultrasound guided airway nerve block for Endotracheal intubationpatients will be intubated using the video-assisted laryngoscope after taking airway nerves block guided by ultrasound device |
| Group T | Active comparator | Procedure: lidocaine topical anesthesia for Endotracheal intubationpatients 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided airway nerve block for Endotracheal intubationGlossopharyngeal 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. | Procedure or surgery | Group LA |
| lidocaine topical anesthesia for Endotracheal intubationwill receive topical lidocaine 10% spray directly on the tongue and oropharynx without exceeding toxic doses. | Procedure or surgery | Group T |
Primary outcome
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
1 secondary outcome
Mean blood pressure (MAP)
Time frame: After applying local anesthesia by at least 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Derived from this study: PubMed 42180592Hashim RM, Zaki MSM, Elagiby DBN, Taher IAA. Ultrasound-Guided Airway Nerve Blocks vs. Lidocaine Topical Anesthesia Using Video-Assisted Laryngoscopy in Suspected Difficult Intubation for Patients Undergoing Bariatric Surgery: A Randomized Clinical Trial. Anesthesiol Res Pract. 2026 May 22;2026:2054379. doi: 10.1155/anrp/2054379. eCollection 2026.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
Related trials for Gag Reflex
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Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination
Gag Reflex, Child
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Effective Interventions to Overcome Severe Gag Reflex
Gagging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Nabih, M.B.B.CH principal investigator
Anesthesia resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided airway nerve block for Endotracheal intubation and lidocaine topical anesthesia for Endotracheal intubation in people with Gag Reflex, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Gag reflex and cough reflex (time frame: After applying local anesthesia by at least 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07069686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.