Comparative of Video Laryngeal Mask and Endotracheal Intubation in Patients Undergoing Tympanoplasty Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-07-17

Brief Summary

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The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated.

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Detailed Description

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Procedures to be performed under general anesthesia are performed by placing endotracheal intubation and laryngeal mask in the airway. Video Laryngeal Mask (LMA) combines the upper glottic airway device with video laryngoscope tracheal intubation. LMA placement and tracheal intubation can be visualized, LMA position can be continuously monitored during the operation, and adverse events such as LMA displacement can be managed in a timely manner. Studies have shown that video LMA has extraordinary advantages in airway management. This study aimed to compare video LMA and endotracheal intubation in participants who will undergo tympanoplasty surgery.

Conditions

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Tympanoplasty Surgery Laryngeal Mask Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group Laryngeal Mask Airway

In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously. A laryngeal mask will be placed after induction, the cuf will be inflated and fixed with a cuf manometer.

Group Type ACTIVE_COMPARATOR

Video Laryngeal Mask

Intervention Type OTHER

Video laryngeal mask will be used in this group

Group Endotracheal Tube

In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously, 1 mcg/kg fentanyl will be administered intravenously. Additionally, 0.6 mg/kg rocuronium will be administered intravenously and endotracheal intubation will be performed, and the cuff will be inflated and fixed with a cuff manometer.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type OTHER

Endotracheal intubation will be performed in this group.

Interventions

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Video Laryngeal Mask

Video laryngeal mask will be used in this group

Intervention Type OTHER

Endotracheal intubation

Endotracheal intubation will be performed in this group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants aged 18-75
* Participants with ASA I-II-III
* Cases with surgery duration of less than two hours

Exclusion Criteria

* Participants under 18 years of age
* Participants who are pregnant
* Participants with a difficult airway diagnosis
* Participants with a mouth opening of less than 4 cm

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No