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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management; Hypertension, Malignant
• Intervention / Treatment: Device: Ambu aura-i LMA

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients aged from 18 to 60 years presented with brain lesions undergoing craniotomies under general anaesthesia in supine position.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The ETT group; Oral endotracheal intubation via direct laryngoscopy will be performed. The ETT cuff will be inflated to 25 cmH2O using a manometer.
The LMA group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amr s wahdan, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: October 3, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; airway; Laryngeal Mask Airway
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Hypertension, Malignant
• Other Study ID Numbers: MD-202-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No