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Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery

NCT02125838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-03-28

Study results available
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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.

Conditions

  • Anaesthesia

Interventions

DEVICE

Laryngeal Mask Airway-Supreme

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.

DEVICE

Endotracheal Tube

ETT

Sponsors & Collaborators

  • Dokuz Eylul University

    lead OTHER

Principal Investigators

  • SULE OZBİLİGİN, M.D. · STUDY DESİGN

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • Turkey (Türkiye)

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02125838 on ClinicalTrials.gov