SevofluraneNCT06601036
Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients
A study testing Sevoflurane and 2% Xylocaine (2 ml ) in people with Sevoflurane and Sedation, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sevoflurane, Sedation, Awake Fiberoptic Intubation
- What is being tested?
- Sevoflurane and 2% Xylocaine (2 ml )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2024to 1 Feb 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 50 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).
Who cannot join
- Patient refusal.
- Patients with bleeding disorders and nasal mass.
- Allergy or intolerance to one of the study medications.
- Patients with uncontrolled systemic diseases.
- patients with gastro-esophageal reflex.
- history of nasopharyngeal surgery or drug abuse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Marwa A Abogabal, MD, 00201004190210, Dr_mora1985@med.tanta.edu.eg
Mohamed Z Wfa, MD
About this study
The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients
Read the detailed description
Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.
For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.
- Conditions
- Sevoflurane, Sedation, Awake Fiberoptic Intubation, Difficult Airway
- Being tested
- Sevoflurane, 2% Xylocaine (2 ml )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Patients will undergo fiberoptic intubation under sevoflurane sedation.
2% Xylocaine (2 ml )Drug
Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane sedation group | Experimental | Patients will undergo fiberoptic intubation under sevoflurane sedation. Receives: Drug: Sevoflurane |
| Awake fiberoptic group | Active comparator | Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block. Receives: Drug: 2% Xylocaine (2 ml ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 4-point Likert scale patient satisfaction (1, very dissatisfied; 2, unsatisfied; 3, satisfied; 4, very satisfied).
Measured: Immediately after intubation
Secondary outcomes (5)
Intubation time
Intubation time (time from insertion of the fiberoptic bronchoscope throughout the nose till confirmation of intubation with capnography)
Measured: Intraoperatively
Heart rate
Heart rate will be recorded on arrival to the operating room as a baseline, immediately prior to fiberoptic intubation, at the time of intubation and then at 1, 3, and 5 minutes after intubation.
Measured: 5 minutes after intubation
Mean arterial pressure
Mean arterial pressure will be recorded on arrival to the operating room as a baseline, immediately prior to fiberoptic intubation, at the time of intubation and then at 1, 3, and 5 minutes after intubation.
Measured: 5 minutes after intubation
Patient's tolerance to endoscopy
The patient's reaction to the placement of the fiberoptic scope will be assessed on a scale of 1 to 5 and will be recorded (1, no reaction; 2, slight grimacing; 3, severe grimacing; 4, verbal objection; 5, defensive movement of head, hands, or feet).
Measured: Intraoperatively
Patient's tolerance to intubation
The patient's reaction to the placement of the endotracheal tube will be assessed on a scale of 1 to 5 and was recorded (1, no reaction; 2, slight grimacing; 3, severe grimacing; 4, verbal objection; 5, defensive movement of head, hands, or feet)
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Abogabal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601036
- Sponsor's protocol ID
- 36264PR591/3/24
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Sedation as an Alternative for Awake Fiberoptic Intubation in Difficult Airway Patients
- ClinicalTrials.gov ID
- NCT06601036
- Acronym / sponsor ID
- 36264PR591/3/24
- Conditions
- Sevoflurane, Sedation, Awake Fiberoptic Intubation, Difficult Airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 19 Sep 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.
The aim of this study is to compare patient satisfaction and intubating conditions with fiber optic intubation under sevoflurane sedation versus airway blocks in difficult airway patients
Detailed description
Awake fiberoptic intubation (AFOI) is a suitable option for anticipated difficult intubation. The ideal condition for AFOI requires a calm, cooperative patient with blunted airway reflexes to facilitate easy intubation, especially if there is difficulty with laryngeal anatomy and/or pathology.
For this purpose, sedative and anxiolytic agents such as benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine are almost always required to relieve the patients from comfort without impairing ventilation. Patient responsiveness and cooperation are almost always required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane sedation group | Experimental | Drug: SevofluranePatients will undergo fiberoptic intubation under sevoflurane sedation. |
| Awake fiberoptic group | Active comparator | Drug: 2% Xylocaine (2 ml )Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 50 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Patients with difficult airway (Mallampati grade 3 and 4 with mouth opening less than 5 cm).
Key exclusion criteria (6 listed)
- Patient refusal.
- Patients with bleeding disorders and nasal mass.
- Allergy or intolerance to one of the study medications.
- Patients with uncontrolled systemic diseases.
- patients with gastro-esophageal reflex.
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 |
|---|---|---|
| SevofluranePatients will undergo fiberoptic intubation under sevoflurane sedation. | Drug | Sevoflurane sedation group |
| 2% Xylocaine (2 ml )Patients will undergo fiberoptic intubation with bilateral Superior Laryngeal Nerve block and Recurrent laryngeal nerve block. | Drug | Awake fiberoptic group |
Primary outcome
Degree of patient satisfaction
Time frame: Immediately after intubation
The degree of patient satisfaction will be assessed on a 4-point Likert scale patient satisfaction (1, very dissatisfied; 2, unsatisfied; 3, satisfied; 4, very satisfied).
5 secondary outcomes
Intubation time
Time frame: Intraoperatively
Heart rate
Time frame: 5 minutes after intubation
Mean arterial pressure
Time frame: 5 minutes after intubation
Patient's tolerance to endoscopy
Time frame: Intraoperatively
Patient's tolerance to intubation
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and 2% Xylocaine (2 ml ) in people with Sevoflurane and Sedation, run by Tanta 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 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa A Abogabal, MD (00201004190210, Dr_mora1985@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of patient satisfaction (time frame: Immediately after intubation). 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 19 Sep 2024.