I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

NCT ID: NCT03760692

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2024-12-01

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.

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).

Conditions

Airway Morbidity; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

i-gel

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

Ambu AuroGain

Intervention Type: DEVICE

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

Interventions

i-gel

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

Intervention Type: DEVICE

Ambu AuroGain

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

Intervention Type: DEVICE

Other Intervention Names

Group i-gel; Group Ambu AuroGain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Sule Ozbilgin

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sule Ozbilgin, MD

Role: STUDY_DIRECTOR

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

Locations

Sureste University Hospital, Department of Anesthesiology and Critical Care

Madrid, , Spain

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

Izmir, , Turkey (Türkiye)

Countries

Spain; Turkey (Türkiye)

Other Identifiers

HUSE 012-ANR-2017

Identifier Type: OTHER

Identifier Source: secondary_id

351-SBKAEK

Identifier Type: -

Identifier Source: org_study_id