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

Not Applicable

Completed

• Conditions: Urologic Surgical Procedures
• Interventions: Device: LMA Supreme; Device: LMA Proseal

• Registration Number: NCT02852135
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-16
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Supreme group	LMA Supreme	The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Supreme group,LMA Supreme was inserted into each patient after anesthesia induction.
LMA Proseal group	LMA Proseal	The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Prosealgroup,LMA Proseal was inserted into each patient after anesthesia induction.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.