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Completed

NCT Number: NCT01909297

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.

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Key information

Conditions

Airway Complication of Anaesthesia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey, 44100, Turkey (Türkiye)

About this study

A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18- 60 YEARS

Exclusion criteria

  • ASA 3-4 patients
  • BMI 40

Treatment and study plan

Proseal LMA

Device

Size 3,4 or 5 supraglottic device with orogastric drainage tube

SUPREMA LMA

Device

Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube

I-GEL LMA

Device

Size 3,4,5 disposable supraglottic device with noninflatable cuff

Primary outcomes

  1. change of oropharyngeal leak pressure

    Time frame: 10min, 30 min ,45 min

    During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)

Secondary outcomes

  1. easiness of insertion of the device

    Time frame: 2 min

    During insertion, easiness of the devices were evaluated by a scale

Other outcomes

  1. postoperative complication

    Time frame: 2 hour after operation

    At the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2013
Registry last updated
Jul 26, 2013

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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