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

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.

Study Overview

• Status: Completed
• Conditions: Injury Throat
• Intervention / Treatment: Device: Nasopharyngeal airway or laryngeal mask airway

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11588
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Nasopharyngeal airway or laryngeal mask airway; Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway
Other: 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.	Device: Nasopharyngeal airway or laryngeal mask airway; Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative soar throat	presence or abscence of soar throat	2-4 hours postoperative

Collaborators and Investigators

• Sponsor: Hala Salah El-Din El-Ozairy
• Investigators: Principal Investigator: Hala S El-Ozairy, MD, Anaesthesia department, faculty of Medicine, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 1, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FMASU R 48/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No