Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

Cairo University (CU)

Status: Completed

Conditions: Hypertension, Malignant; Airway Management

Treatments: Device: Ambu aura-i LMA

Study type: Observational

Funder types: Other

Identifiers

NCT04582227

MD-202-2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
2. Aged 18 to 60 years.
3. ASA 1 or 2.
4. GCS ≥ 13.

Exclusion criteria

1. Patients who are known hypertensive, history of cardiac diseases or chest diseases
2. Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
3. Risk of difficult intubation
4. Extensive intracranial tumours that may affect recovery of patients.

Trial design

120 participants in 2 patient groups

The ETT group

Description:

Oral endotracheal intubation via direct laryngoscopy will be performed. The ETT cuff will be inflated to 25 cmH2O using a manometer.

The LMA group

Description:

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.

Treatment:

Device: Ambu aura-i LMA