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
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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).