I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

NCT02923427 | Completed Results

• 1 other identifier: 266-SBKAEK
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) on ventilation parameters and surgical view during Trendelenburg Position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.

Conditions

Airway Morbidity; Anaesthesia

Keywords

laryngeal mask Supreme; i-gel; laparoscopic gynecological surgery

Outcome Measures

Primary Outcomes (1)

• Airway Seal Pressure Values

  This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ≈20 cm H2O are typically required in routine practice.

  At baseline and at 15, 30 and 60 minutes

Secondary Outcomes (7)

• Visual Quality

  during pneumoperitoneum

• Gastric Tube Insertion

  following airway device insertion up to 5 minutes

• Postoperative Pharyngolaryngeal Morbidity

  postoperative first hour and 24th hour

• Sufficiency of Pneumoperitoneum

  baseline

• Mean Airway Pressure Values

  At baseline and at 15, 30 and 60 minutes

Study Arms (2)

Laryngeal mask Supreme

ACTIVE COMPARATOR

Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance

Device: Laryngeal mask Supreme Evaluation

i-gel

EXPERIMENTAL

Insertion of the "i-gel" and evaluation of its clinical performance

Device: i-gel Evaluation

Interventions

Laryngeal mask Supreme Evaluation DEVICE

Evaluation of clinical performance in terms of Insertion, ventilation and complications

Laryngeal mask Supreme

i-gel Evaluation DEVICE

Evaluation of clinical performance in terms of Insertion,ventilation and complications

i-gel

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists classification group I-II
• between 18-65 years
• undergoing elective laparoscopic gynecological surgery

You may not qualify if:

• Those with any neck or upper respiratory tract pathology
• Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
• Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
• Obese patients (BMI \>35)
• Those with throat pain, dysphagia and dysphonia
• Those with possible or previous difficult airway
• Those with operations planned for longer than 4 hours
• Conversion to laparatomy
• Neuromuscular blocking agent used

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmir, 35340, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Anaesthesiology and Intensive Care, Sule Ozbilgin
• Organization: DorkuzEU

ozbilginsule@gmail.com

905055252901

Study Officials

• Ferim Günenç, MD

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dokuz Eylul University, MD, Anesthesiologists.

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 4, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 27, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)