Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery

• ClinicalTrials.gov Identifier: NCT02125838
• Recruitment Status: Completed
• First Posted: April 29, 2014
• Results First Posted: March 28, 2017
• Last Update Posted: March 28, 2017
• Sponsor: Dokuz Eylul University
• Information provided by (Responsible Party): Sule Ozbilgin, Dokuz Eylul University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anaesthesia	Device: Laryngeal Mask Airway-Supreme; Device: Endotracheal Tube	Not Applicable

Detailed Description:

This prospective, randomized and double-blind study received permission from "Dokuz Eylül University Medical Faculty Non-Interventional Research Ethics Committee" and after obtaining patients' informed consent, 100 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective laparoscopic gynecological surgery were included.

Patients were divided into:

Group 1=>ETT (50 patients) Group 2=>LM-S (50 patients) Patients and surgeons performing the operation were not aware of which airway device was used. The patients in the groups were determined by block randomized methods.

Patients taken to the surgical room were given standard monitoring (non-invasive blood pressure measurements, electrocardiogram, and peripheral oxygen saturation measurements) before anesthesia induction. For preoperative sedation 0.02 mg/kg midazolam IV was administered.

Patients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask.

For anesthesia induction after 2 minutes of 0.2 µg/kg/min remifentanil and 6 mg/kg/hr propofol infusion, IV 1-2 mg/kg propofol was administered. After induction patients were ventilated with 6 L/min 100% fraction of inspired oxygen inspired oxygen fraction oxygen through a face mask. Anesthesia depth was standardized in all patients using bispectral index monitoring. Bispectral index values were held between 40-60. Bispectral index values were maintained in this interval by increasing or decreasing propofol infusion by 1 mg/kg.

Airway devices were inserted by two researchers with more than 5 years experience.

During airway device placement according to patient reactions an extra dose of 0.5 mg/kg propofol was given if necessary.

Anesthetic maintenance was provided by 50% O2/air mixture with 0.1-0.4 µg/kg/min remifentanil and 50-150 µg/kg/hr (3-9 mg/kg/hr) propofol IV infusion.

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.

After LM-S placement the cuff was inflated with air so as to have a pressure below 60 centimeters of water (cuff pressure manometer, Rusch, Germany). Two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal, cuff pressure was measured repeatedly and recorded. At the same time intervals in the ETT group, ETT cuff pressure was measured.

In the ETT group for women no. 7-7.5 tube was used. The ETT cuff was inflated until the leak sound ceased. It was measured with a manometer to remain between 20-30 centimeters of water.

Successful placement of LM or ETT was confirmed by square-shaped waves observed on the capnogram, easy ventilation of the respiration balloon and visible chest movements. After successful placement of the airway device, it was covered to prevent observation of which device was used.

The length of time for successful placement (duration from mouth opening to first successful ventilation), number of tries, and ease of placement were recorded. Ease of placement was evaluated by the anesthetist in charge of the airway as easy, hard or unsuccessful (alternative airway management).

In a situation where airway provision was unsuccessful after 3 tries, patients without placement of LM-S or who could not be intubated were switched to the other group and airway management was provided.

For oropharyngeal leak test after the expiratory valve was closed air was shut off, O2 was reduced to 3 L/min and the first pressure value when a leak sound was heard was recorded as the oropharyngeal leak pressure. To prevent exposure of the lungs to barotrauma, when the peak inspiratory pressure reached 40centimeters of water the expiratory valve was opened and the test was concluded. This test was repeated before peritoneal insufflation, 10 minutes later and immediately before desufflation and was completed by a researcher blind to the type of airway device inserted.

Positive pressure respiration was begun by using a ring system, 2-4 L/min fresh gas flow and 0.5 volume controlled 6-8 ml/kg tidal volume and 10 respirations/min frequency. Positive end expiratory pressure was not administered and I:E ratio was adjusted to 1:2. ETCO2 was held between 35-45 mmHg, if necessary first respiration frequency was increased then tidal volume was increased. Permission was given for CO2 insufflation for the laparoscopic intervention with peritoneal interior pressure of 15 mmHg.

Two minutes after LM-S or ETT placement, before insufflation, 10 minutes after insufflation and trendelenburg position, immediately before peritoneal desufflation and before airway device removal, ventilation parameters were evaluated.

Respiratory measurements to be recorded: Tidal volume (TV), respiration number (RN), peripheral oxygen saturation (SPO2), end-tidal carbon dioxide pressure (PETCO2), peak airway pressure (P peak), mean airway pressure (P mean) and expiration volume per minute (VE).

Hemodynamic measurements to be recorded: (simultaneous to the measurements above and additionally before induction) Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP) and heart rate (HR).

Evaluation related to gastric tube:

Immediately after airway device placement using either the LM-S drainage tube or in intubated patients using a 14 F orogastric probe within the airway, the stomach was reached and the gastric contents were aspirated. Ease of placement and amount of fluids aspirated were recorded. Ease of placement was classified by the person who inserted the orogastric probe as very easy, easy, difficult and very difficult.

The number of interventions with Verres needle, initial intra-abdominal pressure, duration to reach intra-abdominal pressure of 15 mmHg, and insufflated volume of CO2 were recorded. Sufficiency of pneumoperitoneum (sufficient/insufficient), and quality of airway provision were evaluated by the surgeon who was blind to the airway device used by giving points between 1-4.

Immediately after the intra-abdominal laparoscopic intervention and immediately before peritoneal insufflation was ended, gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field) and the difference between the scores at the start and end of the operation was recorded.

When the patient cooperated LM-S or ETT was removed and total anesthesia duration and peritoneal insufflation duration was recorded. Possible complications that could develop during airway device removal (coughing, vomiting, laryngeal stridor, laryngeal spasm or requirement for airway intervention) were recorded.

After laryngeal supra glottic airway device removal the presence of blood was evaluated as

1. no blood
2. trace amounts of blood
3. clear amount of blood Revived patients were taken to the recovery unit and a blind researcher evaluated the patients' throat pain, hoarseness and presence of difficulty swallowing in the 1st and 24th hours. To evaluate throat pain the visual analogue scale was used.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Application of Endotracheal Intubation and Laryngeal Mask Supreme Without Neuromuscular Blocker in Laparoscopic Gynecologic Surgery
• Study Start Date: May 2013
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group ETT; 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; ETT; Other Name: Group ETT
Experimental: Group LMS; 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; 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.; Other Name: Group LM-S

Outcome Measures

Primary Outcome Measures :

1. Asses to Ventilation Parameters [ Time Frame: intraoperative period ]
   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
2. Asses to Peak Pressure [ Time Frame: intraoperative period ]
   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
3. Asses to Mean Pressure [ Time Frame: during procedure ]
   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

Secondary Outcome Measures :

1. Quality of View According to Surgeon by Rate Scale [ Time Frame: intraoperative period ]

   Quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale.

   Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)

2. Evaluation of Gastric Distention [ Time Frame: Baseline ]
   To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)
3. Ease of Orogastric Tube Placement Classification [ Time Frame: Baseline ]
   Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.
4. Haemodynamic Response to Insertion of Airway Device [ Time Frame: Baseline ]
   Systolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .
5. Incidence of Post-operative Sore Throat [ Time Frame: Baseline ]
   Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Turkey

Sule Ozbilgin

Izmi̇r, Narlıdere, Turkey, 35320

Sponsors and Collaborators

Dokuz Eylul University

Investigators

• Principal Investigator: SULE OZBİLİGİN, M.D.; STUDY DESİGN

More Information

• Responsible Party: Sule Ozbilgin, Anaesthesiology and Reanimation, Dokuz Eylul University
• ClinicalTrials.gov Identifier: NCT02125838
• Other Study ID Numbers: 859-GOA
• First Posted: April 29, 2014
• Results First Posted: March 28, 2017
• Last Update Posted: March 28, 2017
• Last Verified: February 2017

Keywords provided by Sule Ozbilgin, Dokuz Eylul University:

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