Anaesthesia Clinical Trial
Official title:
Comparison of I-gel and LMA Supreme Without Neuromuscular Blocker in Laparoscopic Gynecological Surgery
NCT number | NCT02923427 |
Other study ID # | 266-SBKAEK |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | November 2017 |
Verified date | October 2020 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation | Izmir |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
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 |
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