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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852135
Other study ID # LMA-lateral-laparoscopic
Secondary ID
Status Completed
Phase N/A
First received April 16, 2016
Last updated March 7, 2017
Start date July 2016
Est. completion date December 2016

Study information

Verified date March 2017
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The patients belong to ASA physical status grade I and ?, 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group The equilibrating airway pressure was recorded when an audible leak occurred over the mouth. intraoperative
Secondary Ventilatory efficiency scores for the LMAs intraoperative
Secondary Adverse effects in two groups The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat. intraoperative
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