CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Laryngeal Mask Airway-Supreme +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02125838
NCT02125838N/ACompleted

Application of Endotracheal Intubation and Laryngeal Mask Supreme Without Neuromuscular Blocker in Laparoscopic Gynecologic Surgery

Dokuz Eylul University·interventional·Posted Apr 29, 2014·Updated Mar 28, 2017

In Brief

A clinical study evaluating Laryngeal Mask Airway-Supreme and Endotracheal Tube for Anaesthesia. Completed, enrolled 108 participants across 1 site.

Detailed Summary

Laryngeal mask (LM) use in gynecological laparoscopy, contrary to widespread opinion, does not increase the incidence of gastric aspiration, the failure of ventilation or the risk of pulmonary aspiration . LM is presented as an alternative to endo tracheal tube (ETT) in spontaneous or positive pressure ventilation (PPV) . LM has gained widespread popularity in England for gynecological laparoscopic procedures. In addition in many previous studies LM has been successfully shown to provide appropriate lung ventilation in laparoscopic surgical interventions .Miller et al. compared the use of ETT, LM-P laparoscopic gynecological interventions and identified advantages to LM use. The most important of these advantages was that, contrary to tracheal tube techniques for laparoscopic surgeries, use of supraglottic laryngeal devices or neuromuscular blocker agents (NBA) were not required during placement. Thus for laparoscopic surgeries, compared with the ETT technique, without the need for supraglottic laryngeal devices or muscular relaxants, it is easily placed and reduces the time spent in the operating room. Our aim; to compare the use of LM-S and ETT without neuromuscular agents for laparoscopic gynecological intervention with positive pressure ventilation from a surgical viewpoint and in terms of effect on ventilation parameters. Secondary aim, comparison of airway morbidity with endotracheal intubation and supraglottic.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaesthesia
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2014
Enrollment StartMay 1, 2013
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.2 years ago

Interventions

Laryngeal Mask Airway-Supremedevice

Group LM-S (Laryngeal Mask Airway-Supreme)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For \<50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.

Endotracheal Tubedevice

ETT