MedPath

Comparison of the effect of the use of the i-gel, a supraglottic device, on airway clearance and effectiveness in patients in the lateral position.

Not yet recruiting
Conditions
Patients scheduled for surgery and induction of general anesthesia with muscle relaxants
Registration Number
jRCT1042240192
Lead Sponsor
Intersurgical
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
100
Inclusion Criteria

Patients who will undergo induction of general anesthesia with muscle relaxants in the regular medical care at Hamamatsu University Hospital between August 2024 and March 2026.

Exclusion Criteria

Patients who meet any of the following criteria are not eligible for this study

  1. Patients for whom intubation is clinically indicated due to severe obesity or severely compromised respiratory function.
  2. Patients in whom the administration of muscle relaxants is inappropriate or unnecessary for the performance of general anesthesia or surgery.
  3. Patients for whom induction of anesthesia with intravenous anesthetics (propofol or midazolam) is considered inappropriate.

Study & Design

Study Type
Interventional
Study Design
parallel assignment
Primary Outcome Measures
NameTimeMethod
i-gel information

size, insertion time, number of insertions, insertion status index, and number of size changes

Leak pressure, expiratory volume, and glottal findings during ventilation

Leak pressure, expiratory volume, and glottal findings during ventilation (see figure below)

Information after i-gel extubationafter i-gel extubation

blood adherence, postoperative hoarseness, postoperative dysphagia, postoperative dysphonia, and intubation transition

Background of the subject

age, gender, smoking history, lung disease history, sleep apnea history, cervical spine lesion history, respiratory status interview including presence or absence of snoring, and surgical procedure

Physical examination

Height, weight, dental condition, and head and neck condition, including degree of aperture

Clinical examinationwithin the scope of the preoperative examination

pulmonary function tests (lung capacity, rate per second), biochemical tests (AST (GOT), ALT (GPT), LDH, ALP, cholinesterase, LAP, gamma-GTP, amylase, BNP, urea nitrogen, creatinine, CRP)

Secondary Outcome Measures
NameTimeMethod
leak pressure

Assess leak pressure during ventilation in the supine position with the i-gel and i-gel plus.

expiratory volume

Assess expiratory volume during ventilation in the supine position with the i-gel and i-gel plus.

glottal findings

Assess glottal findings during ventilation in the supine position with the i-gel and i-gel plus.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.