I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

Anaesthesia Clinical Trial

Official title:

Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923427
• Other study ID #: 266-SBKAEK
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: October 2020
• 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity
• Anaesthesia

Intervention

Device:
• Laryngeal mask Supreme Evaluation
Evaluation of clinical performance in terms of Insertion, ventilation and complications
• i-gel Evaluation
Evaluation of clinical performance in terms of Insertion,ventilation and complications

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway Seal Pressure Values	This value is important as it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. It is also used in LMA studies as an index of successful placement.Airway pressures of ˜20 cm H2O are typically required in routine practice.	At baseline and at 15, 30 and 60 minutes
Secondary	Visual Quality	quality of surgical view will evaluate by the scala. quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device; (1:best, 4: worst).	during pneumoperitoneum
Secondary	Gastric Tube Insertion	Number of Participants According to Ease of Gastric Tube Insertion.Ease of passage of a gastric tube as: very easy, easy, difficult or very difficult.	following airway device insertion up to 5 minutes
Secondary	Postoperative Pharyngolaryngeal Morbidity	Sore throat evaluted by Visual Analogue Scale. The visual analog scale, also known as the graphic rating scale is a simple, valid and reliable subjective measure. Scores are ranked on a 10-cm line that stretches between two extremes - "no pain" and "worst pain". Total range provided"0 (no pain) to 10 (worst pain).	postoperative first hour and 24th hour
Secondary	Sufficiency of Pneumoperitoneum	Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.	baseline
Secondary	Mean Airway Pressure Values	Mean airway pressure typically refers to the mean pressure applied during positive-pressure mechanical ventilation. Mean airway pressure correlates with alveolar ventilation, arterial oxygenation, hemodynamic performance, and barotrauma.	At baseline and at 15, 30 and 60 minutes
Secondary	Dysphonia With Yes/no.	We evaluated while a patient was talking with us that the patient has dysphonia or not .	postoperative first hour and 24th hour
Secondary	Disphagia	We asked the question that you have a pain while you were swallowing, yes or not.	postoperative first hour and 24th hour