NCT03760692

I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	i-gel	Evaluation of clinical performance in terms of insertion, ventilation and complications
DEVICE	Ambu AuroGain	Evaluation of clinical performance in terms of insertion, ventilation and complications

Timeline

• Start date: 2018-11-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2018-11-30
• Last updated: 2022-03-28

Locations

2 sites across 2 countries: Spain, Turkey (Türkiye)