Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery

NCT02125838 | Completed Results

• 1 other identifier: 859-GOA
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laryngeal mask Supreme; laparoscopic gynecologic surgery; Laryngeal mask during surgery

Outcome Measures

Primary Outcomes (3)

• Asses to Ventilation Parameters

  tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

  intraoperative period

• Asses to Peak Pressure

  peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

  intraoperative period

• Asses to Mean Pressure

  mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device

  during procedure

Secondary Outcomes (5)

• Quality of View According to Surgeon by Rate Scale

  intraoperative period

• Evaluation of Gastric Distention

  Baseline

• Ease of Orogastric Tube Placement Classification

  Baseline

• Haemodynamic Response to Insertion of Airway Device

  Baseline

• Incidence of Post-operative Sore Throat

  Baseline

Study Arms (2)

Group ETT

ACTIVE COMPARATOR

Group endotracheal tube In the endotracheal tube group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Sdn. Bhd. Malaysia. Ref:112482

Device: Endotracheal Tube

Group LMS

EXPERIMENTAL

Laryngeal mask airway-supreme Group In the LMS group 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) will insert.

Device: Laryngeal Mask Airway-Supreme

Interventions

Laryngeal Mask Airway-Supreme DEVICE

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.

Also known as: Group LM-S

Group LMS

Endotracheal Tube DEVICE

ETT

Also known as: Group ETT

Group ETT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification group I-II
• Between 18-65 years
• Undergoing elective laparoscopic gynecological surgery

You may not qualify if:

• Individuals with any neck and upper respiratory pathology
• Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
• Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
• Obese patients (BMI \>35)
• Individuals with sore throat, dysphagia and dysphonia
• Individuals with possibility or history of difficult airway
• Operation time planned for more than 4 hours

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Sule Ozbilgin

Izmi̇r, Narlıdere, 35320, Turkey (Türkiye)

Location

Results Point of Contact

• Title: Sule Ozbilgin
• Organization: DorkuzEU

ozbilginsule@gmail.com

902324122836

Study Officials

• SULE OZBİLİGİN, M.D.

  STUDY DESİGN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: April 29, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Locations

TU (1)