Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

Study Overview
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Brief Summary
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the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.

Detailed Description
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In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.

Official Title
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The Effect of Using Ambu Aura-i Laryngeal Mask Airway Versus Endotracheal Tube on Emergence Hypertension in Supratentorial Cranial Surgery: A Randomized Controlled Study

Conditions
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Hypertension, Malignant, Airway Management

Intervention / Treatment
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* Device: Ambu aura-i LMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position. Aged 18 to 60 years. ASA 1 or 2. GCS ≥ 13. Exclusion Criteria: Patients who are known hypertensive, history of cardiac diseases or chest diseases Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery). Risk of difficult intubation Extensive intracranial tumours that may affect recovery of patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The ETT group<br>Oral endotracheal intubation via direct laryngoscopy will be performed. The ETT cuff will be inflated to 25 cmH2O using a manometer. | |
| The LMA group<br>The Ambu aura-i LMA size will be chosen and inserted using the recommended single-handed rotational technique. Subsequently, a manometer was used to inflate the cuff to 60 cm H2O. | Device: Ambu aura-i LMA<br>* The ETT or the LMA will be inserted with the patient's head position is aided either by pins or head rest, and either the head will be in neutral position or tilted as long as the airway device is successfully placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Mean blood pressure | incidence of emergence hypertension | UP TO 1 HOURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Mean Heart rate | incidence of tachycardia or bradycardia with emergence. | UP TO 1 HOURE | 
| successful placement of the airway device | Number of attempts needed for successful placement of the airway device | UP TO 1 HOURE | 
| incidence of postoperative complication | incidence of postoperative sore throat , hoarseness | up to 24 hours | 
| amount of fentanyl | by microgram | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, airway, Laryngeal Mask Airway