I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anesthesia; Airway Morbidity
• Intervention / Treatment: Device: i-gel; Device: Ambu AuroGain

Detailed Description

Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.

The patients are randomly assigned to 2 groups:

Group i-gel Group Ambu AuraGain

Procedure:

The investigation protocol contains the following sections:

1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.
2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).
3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations.
4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 4-10 mg/kg/hr propofol IV infusion
5. Functionality of the gastric drainage channel of the airway device
6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.
7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.
8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 < 92%)
9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no).

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Sureste University Hospital, Department of Anesthesiology and Critical Care
• Turkey
  • Izmir, Turkey
    • Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA classification I-II
• Between 18-65 years
• Undergoing elective laparoscopic gynecological surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group i-gel; 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; Evaluation of clinical performance in terms of insertion, ventilation and complications; Other Names: Group i-gel
Experimental: Group Ambu Auragain; 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; Evaluation of clinical performance in terms of insertion, ventilation and complications; Other Names: Group Ambu AuroGain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts at insertion	The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.	intraoperative

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Director: Sule Ozbilgin, MD, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic gynecological surgery; supraglottic airway device
• Other Study ID Numbers: 351-SBKAEK; HUSE 012-ANR-2017 (Other Identifier: Hospital Universitario del Sureste)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No