I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03760692
• Other study ID #: 351-SBKAEK
• Secondary ID: HUSE 012-ANR-201
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 102
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity
• Anesthesia

Intervention

Device:
• i-gel
Evaluation of clinical performance in terms of insertion, ventilation and complications
• Ambu AuroGain
Evaluation of clinical performance in terms of insertion, ventilation and complications

Locations

Country	Name	City	State
Spain	Sureste University Hospital, Department of Anesthesiology and Critical Care	Madrid
Turkey	Dokuz Eylul University, School of Medicine, Department of Anesthesiology and Intensive Care	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Countries where clinical trial is conducted

Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion time	The time taken to successfully place the device in seconds	intraoperative
Primary	Change in airway seal pressure	The maximum oropharyngeal leak pressure attained for each device.	intraoperative
Secondary	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