Clinical trial NCT06766253: The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Under General Anesthesia
Official title: The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sore-throat
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Laryngeal mask and tracheal intubation are the two most commonly used airway management methods for patients under general anesthesia. Compared with tracheal intubation, laryngeal mask has the advantages of simple insertion, less airway injury, and more stable hemodynamics. Therefore, laryngeal mask has been widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the British National Health Service system receive anesthesia surgery with different types of airway management every year, and the usage rate of laryngeal mask is higher than that of tracheal intubation, accounting for about 56.2%.

Many new laryngeal masks have been improved based on the classic laryngeal mask and applied to clinical practice. Currently, there are two main types of laryngeal masks: inflatable laryngeal masks and non-inflatable laryngeal masks. Inflatable laryngeal masks are traditional types, including BlockBuster, Superme, ProSeal, and Fastrach, which are the most widely used in clinical practice. Traditional laryngeal masks require inflation to achieve sealing of the throat opening, but inflatable laryngeal masks have drawbacks such as inconvenient insertion, higher incidence of oral and pharyngeal injury and bleeding, and a higher incidence of postoperative sore throat. According to report, the incidence of postoperative sore throat with laryngeal masks is up to 31.9%.

The non-inflatable laryngeal mask is mirrored at the throat opening and made of thermoplastic elastomer material, which achieves a gas tightness effect similar to the inflatable laryngeal mask, improves the ease of insertion, and reduces complications such as sore throat and mucosal injury and bleeding. The i-gel laryngeal mask is the most commonly used non-inflated laryngeal mask currently. A meta-analysis found that the incidence of postoperative sore throat with the i-gel laryngeal mask is 4.1%, which is significantly lower than that of inflatable laryngeal masks.

GMA-TULIP is a new type of non-inflatable laryngeal mask with advantages such as C-shaped double gastric tube channel, stable platform for tongue root, soft tissue sealing ring, epiglottis attached protrusion, and consistent with the anatomical structure of the throat. In addition, the front cuff of GMA-TULIP is small, which only needs to reach the two sides of the pyriform fossa in the distal end. During placement, it passes over the tongue root and reaches the standard position. Compared with i-gel non-inflatable laryngeal mask, GMA-TULIP is more in line with the anatomical position design, theoretically better in position, less likely to cause damage to the throat and pharynx, thus, lower incidence of postoperative sore throat.

In laparoscopic surgeries with trendelenburg position under general anesthesia, the airway pressure is significantly higher than that in the supine position and non-laparoscopic surgery, thus, the incidence of postoperative sore throat is higher than that in the supine position and non-laparoscopic surgery. Therefore, this project intends to compare the 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, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.

Eligibility criteria: Inclusion Criteria:

1. Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours.
2. Ages between 18 to 80, and body mass index less than 28 kg/m².
3. American Society of Anesthesiologists (ASA) Grades I-III.
4. Patients are willing to participate and be able to understand and sign an informed consent form.

Exclusion Criteria:

1. Patients with a mouth opening less than 2 cm.
2. Patients with risk factors for regurgitation and aspiration of gastric contents.
3. Patients with laryngopharyngeal diseases.
4. Patients with potentially difficult airways.
5. Patients with hearing, intellectual, communication, and cognitive impairments.
6. Any reason that patients could not cooperate with the study or that the researcher deems inappropriate for inclusion in this trial.

Primary outcomes:
measure: Incidence of postoperative sore throat
timeFrame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Secondary outcomes:
measure: incidence of dysphagia
timeFrame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Other outcomes:
measure: Time of insertion
timeFrame: 1 min after successful insertion of the laryngeal mask
measure: Times of laryngeal mask adjustment before the successful insertion
timeFrame: 1 min after the airway is successfully controlled.
measure: The rate of first-insertion success
timeFrame: 1 min after the first-attempt insertion of the laryngeal mask
measure: Total insertion success rate
timeFrame: 1 min after the airway is successfully controlled.
measure: Success rate of gastric tube insertion through laryngeal mask
timeFrame: 1 min after the laryngeal mask is successful inserted
measure: grade of view on fibreoptic bronchoscopy
timeFrame: 1 min after successful insertion of the laryngeal mask, 5 min after pneumoperitoneum and trendelenburg position
measure: oropharyngeal leak pressure
timeFrame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
measure: Peak airway pressure
timeFrame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
measure: Airway plateau pressure
timeFrame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
measure: heart rate
timeFrame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
measure: diastolic blood pressure
timeFrame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
measure: systolic blood pressure
timeFrame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
measure: mean arterial pressure
timeFrame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
measure: Times of intraoperative air leakage
timeFrame: From the start of anesthesia to the end of the anesthesia
measure: Times of laryngeal mask adjustment during the operation
timeFrame: From the start of anesthesia to the patient's exit from the operating room
measure: The incidence of aspiration
timeFrame: From the start of anesthesia to the patient's exit from the operating room
measure: The incidence of regurgitation
timeFrame: From the start of anesthesia to the patient's exit from the operating room
measure: incidence of blood staining on the laryngeal mask
timeFrame: 1 min after the laryngeal mask is pull out after surgery.
measure: The incidence of cough
timeFrame: the time when the laryngeal mask is pull out
measure: Active mouth bleeding rate
timeFrame: 1 min after laryngeal mask removal
measure: Time of laryngeal mask application
timeFrame: 1 min after the laryngeal mask is withdrawn
measure: Length of surgery
timeFrame: 1 min after the end of surgery
measure: The incidence of hoarseness
timeFrame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Bing Chen
role: PRINCIPAL_INVESTIGATOR
References: