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NCT04186455 Clinical Trial

Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study

Ureteral Calculi Clinical Trial

Official title:
Comparison of Pro Seal and Baska-mask

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04186455
Other study ID # KAEK 2019/68
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2019
Est. completion date February 7, 2022

Study information
Verified date February 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.

Description:

The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date February 7, 2022
Est. primary completion date February 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:18-65 years of age - undergoing elective urs operations - bmi<35 - ASA I-II Exclusion Criteria:<18 years of age - bmi>35 - ASA III-IV

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• proseal
laryngeal mask proseal
• baska-mask
laryngeal mask baska-mask

Locations
Country Name City State
Turkey Kocaeli University Medical Faculty Kocaeli

Sponsors (1)
Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary insertion time insertion time of the laryngeal mask 20 seconds
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