Intracranial Pressure Increase Clinical Trial
Official title:
The Effect of Supralottic Airway Devicess on Hemodynamic Response and Optic Nerve Sheath Diameter. PROSEAL LMA, SUPREMA LMA, I-JEL LMA
NCT number | NCT05499754 |
Other study ID # | 2019/09 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | July 30, 2020 |
Verified date | August 2022 |
Source | Zonguldak Bulent Ecevit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Direct laryngoscopy and tracheal intubation are associated with increases in intraocular pressure (IOP), intracranial pressure (ICP), heart rate (HR), and blood pressure. The use of supraglottic airway devices (SADs) are known to be beneficial in overcoming the disadvantages of laryngoscopy and tracheal intubation, especially ocular and pressure stress responses. In recent years, it has been reported that ultrasonographic measurement of optic nerve sheath diameter (ONSD) can be used in the diagnosis of increased ICP. The aim of our study is to compare the effects of Proseal laryngeal mask airway (pLMA), Suprem laryngeal mask airway (sLMA) and I-gel on hemodynamic response and ONSD during insertion in adult patients.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 30, 2020 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ASA physical status of I-II - elective surgery - non-ophthalmic procedures - 1-2 h duration - general anaesthesia - supine position Exclusion Criteria: - Mallampati and ASA status =III, - a history or suspect of difficult airway, - previous intracranial/ocular surgery, - cerebral edema/high intracranial pressure, - glaucoma, - uncontrolled hypertension -, diabetic retinopathy, - obstetric patients, - those who refused to participate in the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Gamze Küçükosman | Zonguldak |
Lead Sponsor | Collaborator |
---|---|
Zonguldak Bulent Ecevit University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OPTIC NERVE SHEATH DIAMETER | effects of different types of laryngeal masks onoptic nerve sheath diameter | 10 min after using supraglottic airway devices |
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