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

NCT ID: NCT01345747

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Focus Groups

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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laryngeal tube

laryngeal tube suction has suction port

Group Type EXPERIMENTAL

laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Intervention Type DEVICE

laryngeal tube suction number 3 and 4

endotracheal tube

Group Type EXPERIMENTAL

laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Intervention Type DEVICE

laryngeal tube suction number 3 and 4

Interventions

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laryngeal tube (VBM Medizintechnik, Sulz, Germany)

laryngeal tube suction number 3 and 4

Intervention Type DEVICE

Other Intervention Names

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The laryngeal tube(VBM Medizintechnik, Sulz, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand

Locations

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Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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LT-Laparo

Identifier Type: -

Identifier Source: org_study_id

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