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OpenTrials
Completed

NCT Number: NCT05499754

Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gamze Küçükosman

Zonguldak, 67600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL

Other

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.

Primary outcomes

  1. OPTIC NERVE SHEATH DIAMETER

    Time frame: 10 min after using supraglottic airway devices

    effects of different types of laryngeal masks onoptic nerve sheath diameter

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

The Effect of Supralottic Airway Devicess on Hemodynamic Response and Optic Nerve Sheath Diameter. PROSEAL LMA, SUPREMA LMA, I-JEL LMA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2022
Registry last updated
Aug 12, 2022

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.

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