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

I

Inonu University

Status

Completed

Conditions

Airway Complication of Anaesthesia

Treatments

Device: PROSEAL LMA
Device: SUPREMA LMA
Device: I-GEL LMA

Study type

Interventional

Funder types

Other

Identifiers

NCT01909297
2011/188

Details and patient eligibility

About

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.

Full description

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).

Enrollment

35 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18- 60 YEARS

Exclusion criteria

  • ASA 3-4 patients
  • BMI 40

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

35 participants in 3 patient groups

ProSeal LMA
Active Comparator group
Description:
Supraglottic airway device
Treatment:
Device: PROSEAL LMA
suprema LMA
Active Comparator group
Description:
Supraglottic airway device
Treatment:
Device: SUPREMA LMA
I-gel LMA
Active Comparator group
Description:
Supraglottic airway device
Treatment:
Device: I-GEL LMA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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