Clinical trial NCT03510949: Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty
Official title: The Use of Nasopharyngeal Airway as an Alternative to Laryngeal Mask Airway to Maintain Anaesthesia in Patients Undergoing Four-Lids Blepharoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Throat
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 148
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative soar throat
timeFrame: 2-4 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Anaesthesia department, faculty of Medicine, Ain Shams University
name: Hala S El-Ozairy, MD
role: PRINCIPAL_INVESTIGATOR
References: