N/A
N=112
I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
Airway Morbidity · Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02923427 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Airway Seal Pressure Values — 31.20; 27.58; 30.10; 28.76 cm H2O
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laryngeal mask Supreme Evaluation (Device); i-gel Evaluation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dokuz Eylul University
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Seal Pressure Values |
31.20; 27.58; 30.10; 28.76; 29.92; 28.71 | — |
| SECONDARY Visual Quality |
3.941; 3.945 | — |
| SECONDARY Gastric Tube Insertion |
33; 12; 18; 27; 0; 10 | — |
| SECONDARY Postoperative Pharyngolaryngeal Morbidity |
0.43; 0.16; 0.02; 0.00 | — |
| SECONDARY Sufficiency of Pneumoperitoneum |
50; 55; 1; 0 | — |
| SECONDARY Mean Airway Pressure Values |
5.84; 5.82; 7.84; 7.87; 7.45; 7.27 | — |
| SECONDARY Dysphonia With Yes/no. |
51; 55; 51; 55 | — |
| SECONDARY Disphagia |
47; 54; 51; 55 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02923427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.