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Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial

Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial - Comparison of the Effectiveness of the Mandibular Elevation Technique and the Conventional Method in i-gel Insertion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059553
Enrollment
200
Registered
2026-02-01
Start date
2025-10-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Under General Anesthesia

Interventions

During insertion, the i-gel is inserted while lifting the mandible along with the tongue using one hand to create space in the oral cavity. Without rotating the head, the i-gel is inserted in the snif
s chin forward to open the mouth, and advancing it along the hard palate into the oral cavity.

Sponsors

Seirei Mikatahara General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 50 years or older undergoing general anesthesia who require airway management. Patients who provided consent to participate in this study by signing a written informed consent form. [Justification] Since insertion difficulties with the i-gel are rare in younger individuals, the age criterion was set at 50 years or older.

Exclusion criteria

Exclusion criteria: Refusal to participate in the study Day surgery Pre-existing neurological or cognitive disorders Use of antipsychotic medications Body mass index (BMI) over 35 kg/m2 or body weight over 90 kg Mouth opening less than 2.5 cm Acute sore throat Conditions with a risk of aspiration (e.g., pregnancy, gastroesophageal reflux disease, hiatal hernia) History of difficult intubation Limited neck mobility (e.g., atlantoaxial subluxation, history of cervical spine or head and neck surgery)

Design outcomes

Primary

MeasureTime frame
First-Attempt Success Rate of Insertion

Secondary

MeasureTime frame
Success rate within two attempts Time required for successful insertion within two attempts Leak pressure Conversion to tracheal intubation Procedure-related complications assessed in the post-anesthesia care unit

Countries

Japan

Contacts

Public Contactshingo kawashima

Seirei Mikatahara General Hospital Department of Anesthesiology

shingogo@hama-med.ac.jp0534361251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026