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Currently, the main method for selecting an i-gelĀ® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gelĀ® in this cohort.
With the introduction of the laryngeal mask, it has been widely used for the management of airway during general anesthesia. Compared to the endotracheal tube, it has the advantages of easier and faster placing, reducing the proportion of a sore throat and other benefits. The i-gelĀ® is a second-generation of the laryngeal mask. Compared to the classic laryngeal mask, it provides higher sealing pressure and better airway protection to reduce respiratory complications.
Choosing an appropriate size laryngeal mask is an important issue. Trauma during placing or positive ventilation failure may occur if the wrong size is selected. Currently, the main method for selecting an i-gelĀ® size is based on the body weight recommendation (30-60 kg for size 3 and 50-90 kg for size 4) according to the manufacturer's recommendation. However, there is an overlapping in size selection in people weighing between 50 and 60 kilograms. Laryngeal mask airways are widely used for breast surgery, and this patient cohort is often weighed between 50-60 kilograms in National Taiwan University Hospital. Therefore, in this randomized clinical trial, the investigators will compare the ventilation efficacy of size 3 and size 4 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. Also, the investigators will record any side effects of size 3 and size 4 i-gelĀ® in this cohort.
Keywords: Airway management; laryngeal mask airway; breast surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| size 3 i-gelĀ® | Active Comparator | size 3 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
|
| size 4 i-gelĀ® | Experimental | size 4 i-gel supraglottic airway device in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| size 3 i-gel supraglottic airway device | Device | Use size 3 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the ventilation efficacy of size 3 and size 4 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. | Use ventilation score (1 point for presence of each item, a total score from 0 to 3) to evaluate ventilation efficacy. Ventilation score include:
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Compare side effects of size 3 and size 4 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. | Any Side effects include:
| 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TSUNG AN TSAI, MD | Contact | 886-2-23123456 | 62158 | na0822@hotmail.com |
| Ming Hui Hung, MD | Contact | 886-2-23123456 | 62158 | hung.minghui@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Hui Hung, MD | National Taiwan University Hospital Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2026 | |
| Reset | Jan 28, 2026 | |
| Release | Jan 30, 2026 | |
| Reset | Feb 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2026 | Jan 28, 2026 | |||
| Jan 30, 2026 |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| size 4 i-gel supraglottic airway device | Device | Use size 4 i-gelĀ® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery. |
|
| Feb 18, 2026 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |