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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04582227
Other study ID # MD-202-2020
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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