Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty

NCT ID: NCT03510949

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-07-01

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.

Conditions

Injury Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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 Type: OTHER

Nasopharyngeal airway or laryngeal mask airway

Intervention Type: DEVICE

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

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.

Group Type: OTHER

Nasopharyngeal airway or laryngeal mask airway

Intervention Type: DEVICE

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

Interventions

Nasopharyngeal airway or laryngeal mask airway

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hala Salah El-Din El-Ozairy

OTHER

Sponsor Role: lead

Responsible Party

Hala Salah El-Din El-Ozairy

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hala S El-Ozairy, MD

Role: PRINCIPAL_INVESTIGATOR

Anaesthesia department, faculty of Medicine, Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 48/2017

Identifier Type: -

Identifier Source: org_study_id