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

NCT06766253 | Recruiting

• 1 other identifier: 2024.135
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore-throat

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative sore throat

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

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

Secondary Outcomes (1)

• incidence of dysphagia

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

Other Outcomes (23)

• Time of insertion

  1 min after successful insertion of the laryngeal mask

• Times of laryngeal mask adjustment before the successful insertion

  1 min after the airway is successfully controlled.

• The rate of first-insertion success

  1 min after the first-attempt insertion of the laryngeal mask

Study Arms (3)

GMA-TULIP

EXPERIMENTAL

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

Device: GMA-TULIP

i-gel

ACTIVE COMPARATOR

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

Device: GMA-TULIP

BlockBuster

ACTIVE COMPARATOR

Using BlockBuster inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.

Device: GMA-TULIP

Interventions

GMA-TULIP DEVICE

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

BlockBuster; GMA-TULIP; i-gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Bing Chen

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Chen, PhD

CONTACT

+8617323832352; chenbing@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: August 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available when publish and keep it for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (1)