About this trial
This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours.
Ages between 18 to 80, and body mass index less than 28 kg/m².
American Society of Anesthesiologists (ASA) Grades I-III.
Patients are willing to participate and be able to understand and sign an informed consent form.
Disqualifiers
Patients with a mouth opening less than 2 cm.
Patients with risk factors for regurgitation and aspiration of gastric contents.
Patients with laryngopharyngeal diseases.
Patients with potentially difficult airways.
Trial design
Parallel
Treatments tested in this trial
GMA-TULIP
DeviceUsing GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative sore throat
Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)
Secondary outcomes
incidence of dysphagia
Check the patient can swallow or not
Other outcomes
Time of insertion
Insertion time was defined as the time from the opening of the mouth by the operator to the positively insert the laryngeal mask. The time of glottic examination, adjustment between two ventilation insertions, and ventilation was not measured as ventilation insertion time.
Times of laryngeal mask adjustment before the successful insertion
The times of laryngeal mask adjustments before successful laryngeal mask insertion.
The rate of first-insertion success
The first successful insertion is defined as oropharyngeal leak pressure higher than 20 cmH2O and grade 1-2 of the laryngeal view under the fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning) at the first attempt.
Total insertion success rate
The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.