Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres
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|ClinicalTrials.gov Identifier: NCT02852135|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urologic Surgical Procedures||Device: LMA Proseal Device: LMA Supreme||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: LMA Proseal group
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.
Device: LMA Proseal
After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.
Experimental: LMA Supreme group
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.
Device: LMA Supreme
After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.
- oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group [ Time Frame: intraoperative ]The equilibrating airway pressure was recorded when an audible leak occurred over the mouth.
- Ventilatory efficiency scores for the LMAs [ Time Frame: intraoperative ]
- Adverse effects in two groups [ Time Frame: intraoperative ]The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852135
|Study Director:||Liu Yi, D.M||Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433|