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

ConditionSore-throat
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Second Affiliated Hospital of Chongqing Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • GMA-TULIP

    Device

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

Treatment groups

195 Participants
are divided into 3 treatment groups
Group A: GMA-TULIPExperimental treatment 1 intervention
Group B: i-gelActive comparator 1 intervention
Group C: BlockBusterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative sore throat

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

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

Secondary outcomes

1

incidence of dysphagia

Check the patient can swallow or not

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

Other outcomes

1

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.

Time frame
1 min after successful insertion of the laryngeal mask
2

Times of laryngeal mask adjustment before the successful insertion

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

Time frame
1 min after the airway is successfully controlled.
3

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.

Time frame
1 min after the first-attempt insertion of the laryngeal mask
4

Total insertion success rate

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

Time frame
1 min after the airway is successfully controlled.

Sponsors and contacts

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