Clinical trial NCT03760692: I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery
Official title: Comparison of I-gel and Ambu AuraGain Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Morbidity
Anesthesia
Keywords: supraglottic airway device
laparoscopic gynecological surgery
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Insertion time
timeFrame: intraoperative
measure: Change in airway seal pressure
timeFrame: intraoperative
Secondary outcomes:
measure: Number of attempts at insertion
timeFrame: intraoperative
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Sureste University Hospital, Department of Anesthesiology and Critical Care
city: Izmir
country: Turkey
facility: Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
Study officials:
affiliation: Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care
name: Sule Ozbilgin, MD
role: STUDY_DIRECTOR
References: