Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Airway Seal Pressure Values
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists classification group I-II
- •between 18-65 years
- •undergoing elective laparoscopic gynecological surgery
Exclusion Criteria
- •Those with any neck or upper respiratory tract pathology
- •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)
- •Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
- •Obese patients (BMI >35)
- •Those with throat pain, dysphagia and dysphonia
- •Those with possible or previous difficult airway
- •Those with operations planned for longer than 4 hours
- •Conversion to laparatomy
- •Neuromuscular blocking agent used
Outcomes
Primary Outcomes
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 Outcomes
- Mean Airway Pressure Values(At baseline and at 15, 30 and 60 minutes)
- Sufficiency of Pneumoperitoneum(baseline)
- Disphagia(postoperative first hour and 24th hour)
- Visual Quality(during pneumoperitoneum)
- Gastric Tube Insertion(following airway device insertion up to 5 minutes)
- Postoperative Pharyngolaryngeal Morbidity(postoperative first hour and 24th hour)
- Dysphonia With Yes/no.(postoperative first hour and 24th hour)
Investigators
Sule Ozbilgin
Dokuz Eylul University, MD, Anesthesiologists.
Dokuz Eylul University