I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

NCT03760692 | Unknown

• 2 other identifiers: 351-SBKAEKHUSE 012-ANR-2017
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 2

Brief Summary

To compare the effects of i-gel and Ambu AuraGain 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; Anesthesia

Keywords

supraglottic airway device; laparoscopic gynecological surgery

Outcome Measures

Primary Outcomes (2)

• Insertion time

  The time taken to successfully place the device in seconds

  intraoperative

• Change in airway seal pressure

  The maximum oropharyngeal leak pressure attained for each device.

  intraoperative

Secondary Outcomes (1)

• Number of attempts at insertion

  intraoperative

Study Arms (2)

Group i-gel

ACTIVE COMPARATOR

Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance

Device: i-gel

Group Ambu Auragain

EXPERIMENTAL

Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations and evaluation of its clinical performance

Device: Ambu AuroGain

Interventions

i-gel DEVICE

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

Also known as: Group i-gel

Group i-gel

Ambu AuroGain DEVICE

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

Also known as: Group Ambu AuroGain

Group Ambu Auragain

Eligibility Criteria

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

You may qualify if:

• ASA classification 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 GIS 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 laparotomy
• Neuromuscular blocking agent used

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Sureste University Hospital, Department of Anesthesiology and Critical Care

Madrid, Spain

Location

Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care

Izmir, Turkey (Türkiye)

Location

Study Officials

• Sule Ozbilgin, MD

  Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

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: Director

Model Details: Prospective, multicenter, randomized

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 30, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

ES (1); TU (1)