I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery

• ClinicalTrials.gov Identifier: NCT02923427
• Recruitment Status: Completed
• First Posted: October 4, 2016
• Results First Posted: October 8, 2020
• Last Update Posted: October 27, 2020
• Sponsor: Dokuz Eylul University
• Information provided by (Responsible Party): Sule Ozbilgin, Dokuz Eylul University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Airway Morbidity; Anaesthesia	Device: Laryngeal mask Supreme Evaluation; Device: i-gel Evaluation	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: September 2017
• Actual Study Completion Date: November 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Laryngeal mask Supreme; Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance	Device: Laryngeal mask Supreme Evaluation; Evaluation of clinical performance in terms of Insertion, ventilation and complications
Experimental: i-gel; Insertion of the "i-gel" and evaluation of its clinical performance	Device: i-gel Evaluation; Evaluation of clinical performance in terms of Insertion,ventilation and complications

Outcome Measures

Primary Outcome Measures :

1. Airway Seal Pressure Values [ Time Frame: At baseline and at 15, 30 and 60 minutes ]
   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.

Secondary Outcome Measures :

1. Visual Quality [ Time Frame: during pneumoperitoneum ]
   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).
2. Gastric Tube Insertion [ Time Frame: following airway device insertion up to 5 minutes ]
   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.
3. Postoperative Pharyngolaryngeal Morbidity [ Time Frame: postoperative first hour and 24th hour ]
   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).
4. Sufficiency of Pneumoperitoneum [ Time Frame: baseline ]
   Number of Participants with Sufficiency of Pneumoperitoneum. Sufficiency of pneumoperitoneum for the surgical procedure according to surgeon, described as sufficient or insufficient questionaire.
5. Mean Airway Pressure Values [ Time Frame: At baseline and at 15, 30 and 60 minutes ]
   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.
6. Dysphonia With Yes/no. [ Time Frame: postoperative first hour and 24th hour ]
   We evaluated while a patient was talking with us that the patient has dysphonia or not .
7. Disphagia [ Time Frame: postoperative first hour and 24th hour ]
   We asked the question that you have a pain while you were swallowing, yes or not.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

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

İzmir, Turkey, 35340

Sponsors and Collaborators

Dokuz Eylul University

Investigators

• Study Director: Ferim Günenç, MD; Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  Study Documents (Full-Text)

Documents provided by Sule Ozbilgin, Dokuz Eylul University:

Study Protocol and Statistical Analysis Plan  [PDF] December 21, 2017

More Information

• Responsible Party: Sule Ozbilgin, Dokuz Eylul University, MD, Anesthesiologists., Dokuz Eylul University
• ClinicalTrials.gov Identifier: NCT02923427
• Other Study ID Numbers: 266-SBKAEK
• First Posted: October 4, 2016
• Results First Posted: October 8, 2020
• Last Update Posted: October 27, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Sule Ozbilgin, Dokuz Eylul University:

laryngeal mask Supreme; i-gel; laparoscopic gynecological surgery