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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL
a SAD was inserted by all anaesthetists participating in the study had at least 3 years experience of airway management and were experienced with both the pLMA, sLMA and I-jel. Inadequate ventilation after two attempts was considered a failed placement, and these patients were excluded, while the practitioner was freed to use an alternative airway device.

Locations

Country Name City State
Turkey Gamze Küçükosman Zonguldak

Sponsors (1)

Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

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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