Clinical trial NCT02923427: I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
Official title: Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Anaesthesia
Keywords: laryngeal mask Supreme
i-gel
laparoscopic gynecological surgery
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of i-gel and Laryngeal mask airway Supreme (LMA-Supreme) 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, 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 1: i-gel
* Group 2: LMA- Supreme

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. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size of airway device, time an number of attempts.
4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion
5. Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube.
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:

1. American Society of Anesthesiologists classification group I-II
2. between 18-65 years
3. 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 Gastrointestinal system 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 laparatomy
9. Neuromuscular blocking agent used

Primary outcomes:
measure: Airway Seal Pressure Values
timeFrame: At baseline and at 15, 30 and 60 minutes
Secondary outcomes:
measure: Visual Quality
timeFrame: during pneumoperitoneum
measure: Gastric Tube Insertion
timeFrame: following airway device insertion up to 5 minutes
measure: Postoperative Pharyngolaryngeal Morbidity
timeFrame: postoperative first hour and 24th hour
measure: Sufficiency of Pneumoperitoneum
timeFrame: baseline
measure: Mean Airway Pressure Values
timeFrame: At baseline and at 15, 30 and 60 minutes
measure: Dysphonia With Yes/no.
timeFrame: postoperative first hour and 24th hour
measure: Disphagia
timeFrame: postoperative first hour and 24th hour
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
name: Ferim Günenç, MD
role: STUDY_DIRECTOR
References: