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Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty

The Use of Nasopharyngeal Airway as an Alternative to Laryngeal Mask Airway to Maintain Anaesthesia in Patients Undergoing Four-Lids Blepharoplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03510949
Enrollment
148
Registered
2018-04-27
Start date
2018-02-01
Completion date
2018-07-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury Throat

Brief 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 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.

Interventions

DEVICENasopharyngeal airway or laryngeal mask airway

Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway

Sponsors

Hala Salah El-Din El-Ozairy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* consented patients, age: 40-60 years old, ASA II-III

Exclusion criteria

1. Uncontrolled hypertension (systolic blood pressure \> 160 mmHg) or ischaemic heart disease. 2. Pre-existing coagulation defects or anticoagulation medication. 3. Renal impairment. 4. Recent upper respiratory tract infections, asthma, chronic obstructive pulmonary disease, and smoking. 5. History of obstructive sleep apnea. 6. Chronic drug or alcohol abuse. 7. Morbid obesity; BMI \>40 or BMI \>35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes. 8. Allergy to any of the drugs used in the study.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative soar throat2-4 hours postoperativepresence or abscence of soar throat

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026