Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582227
• Other study ID #: MD-202-2020
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: June 22, 2023

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 22, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• Hypertension
• Hypertension, Malignant

Intervention

Device:
• Ambu 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.

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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