An interventional study of Video Laryngeal Mask and Endotracheal intubation in Tympanoplasty Surgery and Laryngeal Mask Airway, sponsored by Samsun University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Samsun University · Not applicable, Interventional, and Other
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.
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.
Samsun University is the lead sponsor of 81 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Video Laryngeal Mask
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.
Other: Endotracheal intubation
Video laryngeal mask will be used in this group
Endotracheal intubation will be performed in this group.
Time to Effective Airway
The time to achieve an effective airway was defined as the time between removing the face mask, attaching the airway device, and obtaining 3 square wave capnograph traces with manual ventilation.
Time frame: Baseline
Number of attempts taken for successful placement of airway device
Number of attempts needed for successful placement of either the SaCoVLM™ video laryngeal mask airway the tracheal tube, as assigned
Time frame: Baseline
Haemodynamic response to insertion of airway device
Systolic blood pressure and heart rate at 0th minute, 1st minute 5th minute, starting from the time the face mask was removed from the patient's face.
Time frame: Baseline, 1st minute, 5th minute
Displacement of the SaCoVLM™ video laryngeal mask in head position
Effect of Head Rotation During Tympanoplasty on laryngeal visibility with the SaCoVLM™ Laryngeal Mask during head rotation
Time frame: Baseline
Incidence of post-operative sore throat
postoperative sore throat will be recorded at 1st hour, 6th hour, 12th hour, 18th hour, 24th hour
Time frame: 24 hours after surgery
Plan to share: No — The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsun University