Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

Completed

• Conditions: Hypertension, Malignant; Airway Management
• Interventions: Device: Ambu aura-i LMA

• Registration Number: NCT04582227
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2020-10-03
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Study Start: 2020-12-01
• Primary Completion: 2023-05-10
• Study Completion: 2023-06-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The LMA group	Ambu aura-i LMA	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.

Primary Outcome Measures

Name	Time	Method
Measure Mean blood pressure	UP TO 1 HOURE	incidence of emergence hypertension

Secondary Outcome Measures

Name	Time	Method
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
Measure Mean Heart rate	UP TO 1 HOURE	incidence of tachycardia or bradycardia with emergence.
amount of fentanyl	up to 24 hours	by microgram

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt