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NCT Number: NCT06766253

The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Under General Anesthesia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location status: Recruiting

Location contact

bing chen, PhD

CONTACT

[email protected]

86 023 62887913

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Patients with hearing, intellectual, communication, and cognitive impairments.
  • Any reason that patients could not cooperate with the study or that the researcher deems inappropriate for inclusion in this trial.

Treatment and study plan

GMA-TULIP

Device

Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.

Primary outcomes

  1. Incidence of postoperative sore throat

    Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

    Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)

Secondary outcomes

  1. incidence of dysphagia

    Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

    Check the patient can swallow or not

Other outcomes

  1. Time of insertion

    Time frame: 1 min after successful insertion of the laryngeal mask

    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.

  2. Times of laryngeal mask adjustment before the successful insertion

    Time frame: 1 min after the airway is successfully controlled.

    The times of laryngeal mask adjustments before successful laryngeal mask insertion.

  3. The rate of first-insertion success

    Time frame: 1 min after the first-attempt insertion of the laryngeal mask

    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.

  4. Total insertion success rate

    Time frame: 1 min after the airway is successfully controlled.

    The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction.

  5. Success rate of gastric tube insertion through laryngeal mask

    Time frame: 1 min after the laryngeal mask is successful inserted

    After the laryngeal mask is successful inserted, a fully lubricated 14F gastric tube was inserted through its esophageal drainage tube

  6. grade of view on fibreoptic bronchoscopy

    Time frame: 1 min after successful insertion of the laryngeal mask, 5 min after pneumoperitoneum and trendelenburg position

    After successful insertion of the laryngeal mask, fiberoptic bronchoscopy was used and graded according to the degree of glottic and epiglottis exposure by a 4-point scale system: 1, full view of glottis; 2, vocal cords, arytenoids, and inferior surface of epiglottis visible; 3, only superior surface of epiglottis visible; 4, no part of epiglottis or larynx visible. The grades 1 and 2 were defined as optimal fiberscopic view.

  7. oropharyngeal leak pressure

    Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position

    After the laryngeal mask is inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, and listen to the neck until the sound of air leakage is heard. The peak airway pressure at this time is the oropharyngeal leak pressure.

  8. Peak airway pressure

    Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position

    Peak pressure refers to the maximum pressure produced by the airflow in the closed circuit each time the ventilator delivers a certain amount of gas from the endotracheal tube to the patient's lungs. Peak airway pressure was measured by the anesthesia machine automatically.

  9. Airway plateau pressure

    Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position

    Plateau airway pressure refers to the pressure that a certain amount of gas remains in the lungs against the entire closed system at the end of the passage of air, before the beginning of exhalation. Airway plateau pressure was measured by the anesthesia machine automatically.

  10. heart rate

    Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn

    heart rate

  11. diastolic blood pressure

    Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn

    diastolic blood pressure

  12. systolic blood pressure

    Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn

    systolic blood pressure

  13. mean arterial pressure

    Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn

    mean arterial pressure

  14. Times of intraoperative air leakage

    Time frame: From the start of anesthesia to the end of the anesthesia

    intraoperative air leakage is defined as hearing an air leak in the pharynx during the operation

  15. Times of laryngeal mask adjustment during the operation

    Time frame: From the start of anesthesia to the patient's exit from the operating room

    the times of the laryngeal mask adjustment during the operation were recorded

  16. The incidence of aspiration

    Time frame: From the start of anesthesia to the patient's exit from the operating room

    The aspiration is defined as seeing the gastric content in the trachea

  17. The incidence of regurgitation

    Time frame: From the start of anesthesia to the patient's exit from the operating room

    The regurgitation is defined as seeing the gastric content in the mouth

  18. incidence of blood staining on the laryngeal mask

    Time frame: 1 min after the laryngeal mask is pull out after surgery.

    When the laryngeal mask was pulled out, the laryngeal mask was stained with blood

  19. The incidence of cough

    Time frame: the time when the laryngeal mask is pull out

    When the laryngeal mask was pulled out, record whether the patient has cough or not.

  20. Active mouth bleeding rate

    Time frame: 1 min after laryngeal mask removal

    After the laryngeal mask was removed, record whether active bleeding occurred at the patient's mouth

  21. Time of laryngeal mask application

    Time frame: 1 min after the laryngeal mask is withdrawn

    The time of laryngeal mask withdrawn minus the time of successful laryngeal mask insertion is the time of laryngeal mask application

  22. Length of surgery

    Time frame: 1 min after the end of surgery

    The end of the surgery time minus the start of the surgery time is the length of surgery

  23. The incidence of hoarseness

    Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

    the patient is hoarse when speaking

Study contacts

Contact information is provided by the study sponsor or research team.

Bing Chen, PhD

CONTACT

[email protected]

+8617323832352

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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