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Clinical Trials/NCT03510949
NCT03510949CompletedNot Applicable

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

Hala Salah El-Din El-Ozairy1 site in 1 country148 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
148
Locations
1
Primary Endpoint
Incidence of postoperative soar throat

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Nasopharyngeal airway or laryngeal mask airway (Device)

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.

Intervention: Nasopharyngeal airway or laryngeal mask airway (Device)

Outcomes

Primary Outcomes

Incidence of postoperative soar throat

Time Frame: 2-4 hours postoperative

presence or abscence of soar throat

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hala Salah El-Din El-Ozairy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hala Salah El-Din El-Ozairy

Lecturer of Anaesthesia, ICU and Pain management, Faculty of Medicine, Ain Shams University

Ain Shams University

Study Sites (1)

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