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Nasopharyngeal Versus Laryngeal Mask Airway in Anaesthesia for Bilateral Blepharoplasty

H

Hala Salah El-Din El-Ozairy

Status

Completed

Conditions

Injury Throat

Treatments

Device: Nasopharyngeal airway or laryngeal mask airway

Study type

Interventional

Funder types

Other

Identifiers

NCT03510949
FMASU R 48/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

148 participants in 2 patient groups

Group N
Other group
Description:
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.
Treatment:
Device: Nasopharyngeal airway or laryngeal mask airway
Group L
Other group
Description:
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.
Treatment:
Device: Nasopharyngeal airway or laryngeal mask airway

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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