Superior Laryngeal Nerve BlockNCT06651905
Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.
A study testing Dexmedetomidine and Superior laryngeal nerve block in people with Superior Laryngeal Nerve Block and Sedation, run by Cairo University at 1 site in Egypt.
Trial summary
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Superior Laryngeal Nerve Block, Sedation, Dexmedetomidine
- What is being tested?
- Dexmedetomidine and Superior laryngeal nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range ≥ 18 or ≤60.
- Both sexes.
- American Society of Anesthesiologists (ASA) II-III.
- Body mass index:18.5 to 30 kg/m2.
- Hemimandibulectomy patients with an anticipated difficult airway [El-Ganzouri Risk Index (EGRI)>3].
Who cannot join
- Patient's refusal.
- Known allergy to drugs used in the study.
- Neurological disorders.
- Advanced liver or kidney disease.
- Patient with psychiatric disorders.
- Patient who needs postoperative ICU.
- Airway distortion and cervical spine movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
- Conditions
- Superior Laryngeal Nerve Block, Sedation, Dexmedetomidine, Awake Fiberoptic Intubation, Hemimandibulectomy, Anticipated Difficult Airway
- Being tested
- Dexmedetomidine, Superior laryngeal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Sedation arm
The patients were given 0.5 mcg /kg dexmedetomidine over 10 min via syringe pump, followed by 0.2-0.7 mcg/kg/hour until the end of intubation according to hemodynamics.
Superior laryngeal nerve blockDrug
Also called Nerve Block arm
The patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Patients were given 0.5 mcg/kg of dexmedetomidine over 10 minutes via a syringe pump, followed by a maintenance dose of 0.2-0.7 mcg/kg/hour until the end of intubation based on Hemodynamics. Receives: Drug: Dexmedetomidine |
| Superior laryngeal nerve block group | Active comparator | Patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve. Receives: Drug: Superior laryngeal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intubation score
The intubation conditions score is assessed based on the following criteria:
(i) Vocal movement: 1 = open, 2 = moving, 3 = closing, 4 = closed. (ii) Coughing: 1 = none, 2 = slight, 3 = moderate, 4 = severe. (iii) Limb movement: 1 = none, 2 = slight, 3 = moderate, 4 = severe.
Where The Intubation conditions score is :
Excellent = 1 when all qualities are excellent. Good = 2 when all qualities are either excellent or good. Poor = 3 when the presence of a single poor quality is noted.
Measured: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes
Secondary outcomes (7)
The degree of comfort
The comfort score was evaluated using a five-point fiberoptic intubation comfort scale: 1 = no reaction, 2 = slight grimace, 3 = heavy grimace, 4 = verbal objection, and 5 = defensive movement of head and hands.
Measured: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes
Degree of airway obstruction
The degree of airway obstruction (1 - absent, 2 - requiring neck extension, 3 - requiring jaw thrust) was noted
Measured: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes
Heart rate
Heart rate is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.
Measured: From one minute before intubation to 10 minutes after intubation
Mean arterial pressure
Mean arterial blood pressure is recorded at 1-minute intervals until intubation is completed, followed by measurements every two minutes until 10 minutes after intubation.
Measured: From one minute before intubation till10 minutes after intubation
Ramsay sedation score
Ramsay sedation score was recorded as follows: 1: Awake, agitated or restless or both; 2: Awake, cooperative, oriented, and tranquil; 3: Awake but responds to commands only; 4: Asleep, with a brisk response to a light glabellar tap or loud auditory stimulus.
Measured: From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation
Patient satisfaction score
The patient satisfaction score (1-excellent, 2-good, 3-reasonable, 4-poor) was documented.
Measured: From the end of the operation to 24 hours postoperative
Incidence of complications
Adverse events such as bradycardia, hypotension, nausea, vomiting, pruritus, respiratory depression, O2 desaturation, or any other complications were recorded.
Measured: From the end of the operation to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Laryngeal Nerve BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Zayed, Cairo University
- Investigators
- Tarek Abd EL Halim Kaddah, MD, Study director, ProfessorMai M EL Rawas, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651905
- Sponsor's protocol ID
- MS-484-2023
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Laryngeal Nerve Block Versus Sedation with Intravenous Dexmedetomidine Infusion for Awake Fiberoptic Intubation of Hemimandibulectomy Patients with an Anticipated Difficult Airway: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06651905
- Acronym / sponsor ID
- MS-484-2023
- Conditions
- Superior Laryngeal Nerve Block, Sedation, Dexmedetomidine, Awake Fiberoptic Intubation, Hemimandibulectomy, Anticipated Difficult Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Oct 2024 (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.
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients were given 0.5 mcg/kg of dexmedetomidine over 10 minutes via a syringe pump, followed by a maintenance dose of 0.2-0.7 mcg/kg/hour until the end of intubation based on Hemodynamics. |
| Superior laryngeal nerve block group | Active comparator | Drug: Superior laryngeal nerve blockPatients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range ≥ 18 or ≤60.
- Both sexes.
- American Society of Anesthesiologists (ASA) II-III.
- Body mass index:18.5 to 30 kg/m2.
- Hemimandibulectomy patients with an anticipated difficult airway [El-Ganzouri Risk Index (EGRI)>3].
Key exclusion criteria (7 listed)
- Patient's refusal.
- Known allergy to drugs used in the study.
- Neurological disorders.
- Advanced liver or kidney disease.
- Patient with psychiatric disorders.
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 |
|---|---|---|
| DexmedetomidineAlso: Sedation armThe patients were given 0.5 mcg /kg dexmedetomidine over 10 min via syringe pump, followed by 0.2-0.7 mcg/kg/hour until the end of intubation according to hemodynamics. | Drug | Dexmedetomidine group |
| Superior laryngeal nerve blockAlso: Nerve Block armThe patients received an airway nerve block through bilateral superior laryngeal nerve block and trans-tracheal injection for recurrent laryngeal nerve. | Drug | Superior laryngeal nerve block group |
Primary outcome
The intubation score
Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes
The intubation conditions score is assessed based on the following criteria: (i) Vocal movement: 1 = open, 2 = moving, 3 = closing, 4 = closed. (ii) Coughing: 1 = none, 2 = slight, 3 = moderate, 4 = severe. (iii) Limb movement: 1 = none, 2 = slight, 3 = moderate, 4 = severe. Where The Intubation conditions score is : Excellent = 1 when all qualities are excellent. Good = 2 when all qualities are either excellent or good. Poor = 3 when the presence of a single poor quality is noted.
7 secondary outcomes
The degree of comfort
Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords. Time range of 10 minutes
Degree of airway obstruction
Time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords Time range of 10 minutes
Heart rate
Time frame: From one minute before intubation to 10 minutes after intubation
Mean arterial pressure
Time frame: From one minute before intubation till10 minutes after intubation
Ramsay sedation score
Time frame: From time of injection of Drugs (Dexetodomidine , Lidocaine) to the patient to 10 minutes after intubation
Patient satisfaction score
Time frame: From the end of the operation to 24 hours postoperative
Incidence of complications
Time frame: From the end of the operation to 24 hours postoperative
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 23 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
Tarek Abd EL Halim Kaddah, MD study director
Professor
Mai M EL Rawas, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Superior laryngeal nerve block in people with Superior Laryngeal Nerve Block and Sedation, run by Cairo 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 5 inclusion and 7 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 23 Oct 2024. 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?
The intubation score (time frame: time from introduction of scope of fibroptic device in the mouth of the patient to the insertion of the endotracheal tube between the vocal cords.Time range of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.