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Completed

NCT Number: NCT01345747

The Laryngeal Tube Suction Versus Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

Background:

For standard procedure, the endotracheal tube is used to ventilate the anesthetized patients who undergo gynecological laparoscopic surgery that increase intrabdominal pressure. Now there is a new supraglottic airway device, laryngeal tube suction (LTs) can be use instead of ETT.

Objective This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Material and methods Prospective single blinded randomized control trial, the patients were divided into two groups, LTs group and ETT group n = 60 for each group. All patients were induced anesthesia with fentanyl 1-2 mcg/kg, propofol 2 mg/kg, vecuronium 0.1 mg/kg then maintained anesthesia with air : oxygen 30%. Respirator setting are tidal volume 10 ml/kg, I/E 1:2 adjust RR base on ETCO2 keep ETCO2 35-40 mmHg.

Results No statistical difference in demographic data between groups. PAP and ETCO2 in the LTs group were significant higher than ETT group in the first 5 and 10 minutes but no statistically significant after 10 minutes until the end of operation. No statistically significant in TV and SpO2 between groups. In ETT group MAP and HR after insertion are significant higher than LTs group, no statistically significant about postoperative complication such as sorethroat, hoarseness and nausea vomiting.

Conclusion LTs can be used in gynecological laparoscopic surgery like ETT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female age between 20-65 years
  • ASA class 1-2
  • elective gynecologic laparoscopic surgery
  • height < 180 cm
  • BMI < 35 kg/m2

Exclusion criteria

  • interincisor gap < 2.5 cm
  • risk of aspiration
  • history of difficult intubation
  • oropharyngeal pathology
  • allergy to anesthetic drug

Treatment and study plan

laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Device

laryngeal tube suction number 3 and 4

Other names: The laryngeal tube(VBM Medizintechnik, Sulz, Germany)

Primary outcomes

  1. respiratory parameter

    Time frame: 1-3 hours

    ETCO2, peak airway pressure and expired TV during operative period

Secondary outcomes

  1. hemodynamic response

    Time frame: 30 minutes

    blood pressure and heart rate after LT insertion

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

The Laryngeal Tube Suction vs Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2011
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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