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NCT Number: NCT07027293

The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients

This prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. A total of 120 patients aged over 75 years with ASA physical status I-III will be randomly assigned to one of four groups: standard position with I-gel, right lateral rotation with I-gel, standard position with classic LMA, and right lateral rotation with classic LMA. The study will compare insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and airway-related complications. The findings aim to provide clinical guidance on the optimal use of supraglottic airway devices in geriatric patients in various head positions.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yadigar Yılmaz

Istanbul, 34230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yadigar Yılmaz

CONTACT

[email protected]

5053069924

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA classification I-III
  • Age over 75 years

Exclusion criteria

  • Known or anticipated difficult airway
  • Contraindications for the use of a supraglottic airway device
  • Patients scheduled for endotracheal intubation

Treatment and study plan

STANDART HEAD POSITION

Other

STANDART HEAD POSITION

HEAD ROTATION POSITION

Other

HEAD ROTATION POSITION

Classic laryngeal mask airway (LMA)

Device

Classic laryngeal mask airway (LMA)

I-gel supraglottic airway device

Device

i-gel supraglottic airway device

Primary outcomes

  1. Insertion Time of Supraglottic Airway Device

    Time frame: 1-10 minutes

  2. Number of attempts for LMA replacement

    Time frame: 15-200 seconds

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Sep 17, 2025

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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