Injury ThroatNCT03510949
Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty
A study testing Nasopharyngeal airway or laryngeal mask airway in people with Injury Throat, run by Hala Salah El-Din El-Ozairy at 1 site in Egypt.
Trial summary
General anaesthesia demands securing patient's airway either with endotracheal tube or laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat. Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar throat.6 The primary end point of our study is to… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Injury Throat
- What is being tested?
- Nasopharyngeal airway or laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Jul 2018
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- consented patients, age: 40-60 years old, ASA II-III
Who cannot join
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg) or ischaemic heart disease.
- Pre-existing coagulation defects or anticoagulation medication.
- Renal impairment.
- Recent upper respiratory tract infections, asthma, chronic obstructive pulmonary disease, and smoking.
- History of obstructive sleep apnea.
- Chronic drug or alcohol abuse.
- Morbid obesity; BMI >40 or BMI >35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
- Allergy to any of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Nasopharyngeal Airway as an Alternative to Laryngeal Mask Airway to Maintain Anaesthesia in Patients Undergoing Four-Lids Blepharoplasty
General anaesthesia demands securing patient's airway either with endotracheal tube or laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat. Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar throat.6 The primary end point of our study is to assess the incidence of soar throat with the use of NPA compared to LMA in patients receiving general anaesthesia during blepharoplasty.
Read the detailed description
After approval of medical ethical committee at Ain-Shams University and obtaining written informed consent, 148 adult ASA II-III patients aged between 40 and 60 years old admitted to Ain-Shams university hospitals for blepharoplasty will be enrolled in this study.
Patients will then be randomly and evenly divided into two equal groups (74 patients each) using computer-generated list:
Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally.
Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
Anaesthesia will be maintained by sevoflurane 3-4% and propofol infusion 0.5-1 mg.kg-1.hr-1.All patients will receive local infiltration anaesthesia given by the surgeon.
At the conclusion of surgery, sevoflurane and propofol infusion will be discontinued and patients will inhale 100% O2 till spontaneous recovery.
Recovery time will be recorded (defined as the time from discontinuation of anaesthetic drugs till response to verbal command).
Incidence of postoperative soar throat, unsteadiness, nausea and vomiting will be recorded as well as patient and surgeon satisfaction.
- Conditions
- Injury Throat
- Being tested
- Nasopharyngeal airway or laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal airway or laryngeal mask airwayDevice
Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| Group N | Other | Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally. Receives: Device: Nasopharyngeal airway or laryngeal mask airway |
| Group L | Other | K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt. Receives: Device: Nasopharyngeal airway or laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative soar throat
presence or abscence of soar throat
Measured: 2-4 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury ThroatStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. The NPA will then be advanced into the dominant nostril along the septum horizontally. Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hala Salah El-Din El-Ozairy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hala Salah El-Din El-Ozairy, Ain Shams University
- Investigators
- Hala S El-Ozairy, MD, Principal investigator, Anaesthesia department, faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510949
- Sponsor's protocol ID
- FMASU R 48/2017
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nasopharyngeal Airway as an Alternative to Laryngeal Mask Airway to Maintain Anaesthesia in Patients Undergoing Four-Lids Blepharoplasty
- ClinicalTrials.gov ID
- NCT03510949
- Acronym / sponsor ID
- FMASU R 48/2017
- Conditions
- Injury Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hala Salah El-Din El-OzairyUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Apr 2018 (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.
General anaesthesia demands securing patient's airway either with endotracheal tube or laryngeal mask (LMA); however, both carry the disadvantage of postoperative soar throat. Nasopharyngeal airway (NPA) can be an alternative without the risk of postoperative soar throat.6 The primary end point of our study is to assess the incidence of soar throat with the use of NPA compared to LMA in patients receiving general anaesthesia during blepharoplasty.
Detailed description
After approval of medical ethical committee at Ain-Shams University and obtaining written informed consent, 148 adult ASA II-III patients aged between 40 and 60 years old admitted to Ain-Shams university hospitals for blepharoplasty will be enrolled in this study.
Patients will then be randomly and evenly divided into two equal groups (74 patients each) using computer-generated list:
Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally.
Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
Anaesthesia will be maintained by sevoflurane 3-4% and propofol infusion 0.5-1 mg.kg-1.hr-1.All patients will receive local infiltration anaesthesia given by the surgeon.
At the conclusion of surgery, sevoflurane and propofol infusion will be discontinued and patients will inhale 100% O2 till spontaneous recovery.
Recovery time will be recorded (defined as the time from discontinuation of anaesthetic drugs till response to verbal command).
Incidence of postoperative soar throat, unsteadiness, nausea and vomiting will be recorded as well as patient and surgeon satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group N: Patients' nasal mucosa will be anaesthetized and vasoconstricted. The NPA will then be advanced into the dominant nostril along the septum horizontally. Group L: K-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt.
| Arm | Type | Receives |
|---|---|---|
| Group N | Other | Device: Nasopharyngeal airway or laryngeal mask airwayPatients' nasal mucosa will be anaesthetized and vasoconstricted. K-Y gel will be applied to the tip of nasopharyngeal airway (NPA) of appropriate size. The NPA will then be advanced into the dominant nostril along the septum horizontally. |
| Group L | Other | Device: Nasopharyngeal airway or laryngeal mask airwayK-Y gel will be applied to the tip of the laryngeal mask (LMA) of appropriate size. The LMA will be introduced along the hard palate towards the hypopharynx until resistance is felt. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- consented patients, age: 40-60 years old, ASA II-III
Key exclusion criteria (8 listed)
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg) or ischaemic heart disease.
- Pre-existing coagulation defects or anticoagulation medication.
- Renal impairment.
- Recent upper respiratory tract infections, asthma, chronic obstructive pulmonary disease, and smoking.
- History of obstructive sleep apnea.
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 |
|---|---|---|
| Nasopharyngeal airway or laryngeal mask airwayComparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway | Device | Group L, Group N |
Primary outcome
Incidence of postoperative soar throat
Time frame: 2-4 hours postoperative
presence or abscence of soar throat
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 3 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hala S El-Ozairy, MD principal investigator
Anaesthesia department, faculty of Medicine, 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 Nasopharyngeal airway or laryngeal mask airway in people with Injury Throat, run by Hala Salah El-Din El-Ozairy 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 1 inclusion and 8 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 3 Jul 2018. 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 postoperative soar throat (time frame: 2-4 hours postoperative). 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 3 Jul 2018.