Skip to main content
OpenTrials
Completed

NCT Number: NCT04582227

Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension, Malignant Airway Management Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo university

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ambu aura-i LMA

Device

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.

Primary outcomes

  1. Measure Mean blood pressure

    Time frame: UP TO 1 HOURE

    incidence of emergence hypertension

Secondary outcomes

  1. Measure Mean Heart rate

    Time frame: UP TO 1 HOURE

    incidence of tachycardia or bradycardia with emergence.

  2. successful placement of the airway device

    Time frame: UP TO 1 HOURE

    Number of attempts needed for successful placement of the airway device

  3. incidence of postoperative complication

    Time frame: up to 24 hours

    incidence of postoperative sore throat , hoarseness

  4. amount of fentanyl

    Time frame: up to 24 hours

    by microgram

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2020
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.