Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04582227

Enrollment

120

Registered

2020-10-09

Start date

2020-12-01

Completion date

2023-06-22

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Hypertension, Malignant

Keywords

Hypertension, airway, Laryngeal Mask Airway

Brief summary

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

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.

Interventions

DEVICEAmbu aura-i LMA

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Measure Mean blood pressure	UP TO 1 HOURE	incidence of emergence hypertension

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026