I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

NCT ID: NCT02923427

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-11-30

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).

Conditions

Airway Morbidity; Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laryngeal mask Supreme

Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance

Group Type: ACTIVE_COMPARATOR

Laryngeal mask Supreme Evaluation

Intervention Type: DEVICE

Evaluation of clinical performance in terms of Insertion, ventilation and complications

i-gel

Insertion of the "i-gel" and evaluation of its clinical performance

Group Type: EXPERIMENTAL

i-gel Evaluation

Intervention Type: DEVICE

Evaluation of clinical performance in terms of Insertion,ventilation and complications

Interventions

Laryngeal mask Supreme Evaluation

Evaluation of clinical performance in terms of Insertion, ventilation and complications

Intervention Type: DEVICE

i-gel Evaluation

Evaluation of clinical performance in terms of Insertion,ventilation and complications

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Sule Ozbilgin

Dokuz Eylul University, MD, Anesthesiologists.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferim Günenç, MD

Role: STUDY_DIRECTOR

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Locations

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

266-SBKAEK

Identifier Type: -

Identifier Source: org_study_id