Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres

Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02852135

Enrollment

186

Registered

2016-08-02

Start date

2016-07-31

Completion date

2016-12-31

Last updated

2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Surgical Procedures

Keywords

Laryngeal Mask Airway, lateral position, laparoscopic surgery

Brief summary

The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

Detailed description

We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation. The patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged\>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Interventions

DEVICELMA Proseal

After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.

DEVICELMA Supreme

After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.

Exclusion criteria

* The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Design outcomes

Primary

Measure	Time frame	Description
oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group	intraoperative	The equilibrating airway pressure was recorded when an audible leak occurred over the mouth.

Secondary

Measure	Time frame	Description
Ventilatory efficiency scores for the LMAs	intraoperative	—
Adverse effects in two groups	intraoperative	The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026