Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06766253

Comparing GMA-TULIP, i-gel, and BlockBuster Laryngeal Masks for Airway Management in Laparoscopic Surgeries with Trendelenburg Position Under General Anesthesia

Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2025-01-09

195

Participants Needed

1

Research Sites

92 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are comparing three types of laryngeal masks used to manage airways during laparoscopic surgeries performed with the Trendelenburg position under general anesthesia. The study aims to determine which laryngeal mask—traditional inflatable BlockBuster, i-gel non-inflatable, or GMA-TULIP non-inflatable—best reduces postoperative throat pain and improves patient comfort and satisfaction. Laryngeal masks are widely used alternatives to tracheal intubation, with non-inflatable types recently developed to reduce complications such as sore throat and mucosal injury. The study evaluates the use of these three laryngeal masks during surgeries expected to last less than three hours in patients positioned in Trendelenburg. The GMA-TULIP mask is a new non-inflatable device designed to better fit throat anatomy and reduce injury, while the i-gel is a commonly used non-inflatable mask. The BlockBuster is a traditional inflatable mask requiring cuff inflation. Each device is applied during general anesthesia to manage the airway. Participants will be monitored for postoperative sore throat at multiple times: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery. The study includes assessments of patient comfort and satisfaction and tracks safety and complications related to airway management. Eligible patients are adults aged 18 to 80 years undergoing specified laparoscopic surgeries with Trendelenburg position, with body mass index below 28 and ASA Grades I-III. The total study involvement includes anesthesia, surgery, and postoperative follow-up within three days after surgery.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing laparoscopic surgeries with Trendelenburg position lasting less than 3 hours
  • Age between 18 and 80 years
  • Body mass index less than 28 kg/m²
  • American Society of Anesthesiologists (ASA) Grades I to III
  • Ability and willingness to understand and sign informed consent form
Not Eligible

You will not qualify if you...

  • Mouth opening less than 2 cm
  • Risk factors for regurgitation and aspiration of gastric contents
  • Presence of laryngopharyngeal diseases
  • Potentially difficult airway
  • Hearing, intellectual, communication, or cognitive impairments
  • Any condition preventing cooperation or deemed inappropriate by the researcher

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400000

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Research Team

B

Bing Chen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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