Comparison of Oropharyngeal Leak Pressures of SaCo Video Laryngeal Mask Airway (LMA) and ProSeal LMA in Adult Elective Surgery

June 30, 2026 updated by: Mehmet Emin Keskin, Yuzuncu Yil University

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

To compare of oropharyngeal leak pressures of SaCo video laryngeal mask airway (LMA) and ProSeal LMA in adult elective surgery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted after obtaining an approval from the local ethics committee. The study will include 180 patients aged 18-65 years with ASA scores I-II, mallampati scores I-II, scheduled for surgery in the supine position in the general surgery, gynecology and obstetrics, urology and orthopedics departments with a planned surgery duration not exceeding 90 minutes. The patients will be randomized by sealed tender and will be divided into 2 groups with 90 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Once sufficient anesthesia depth is achieved, the patient will be prepared to receive either a SaCo video LMA or ProSeal LMA of the appropriate size, according to a randomly assigned group. The successful placement of the LMA on the first attempt, the placement duration and the oropharyngeal leak pressure will be evaluated. Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement. The placement duration will begin with the practitioner holding the patient's head with their left hand and holding the LMA in their right hand. Following successful LMA placement, the cuff will be inflated using a manual cuff pressure gauge until the cuff pressure reaches 60 cm H2O and the pressure valve will be slowly closed, with the values indicating leak pressure being noted. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0,5 mcg/kg fentanyl and 0,15 mg/kg rocuronium will be administered. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The LMA will be removed when the patient starts breathing spontaneously and opens their eyes in response to verbal stimulation. All data will be recorded and statistical analysis will be made.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Tusba
      • Van, Tusba, Turkey (Türkiye), 65100
        • Van Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for electvie surgery in the general surgery, gynecology and obstetrics, urology and orthopedics departments
  • Between 18-65 years
  • ASA I-II group
  • Mallampati scores I-II
  • Patients who will undergo surgery in the supine position
  • Surgeries with a planned duration of no more than 90 minutes.

Exclusion Criteria:

  • Those who are outside the age range of 18-65
  • Those who are ASA III and above
  • Those who are Mallampati score III-IV
  • Patients scheduled for emergency surgery
  • Those whose condition prevents LMA implantation
  • those who have had an upper respiratory tract infection in the last 4 weeks
  • those with a body mass index ≥30 kg/m²
  • those scheduled for laparoscopic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ProSeal LMA (Group-P)
Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA
Procedure: ProSeal LMA Group (Group-P)
Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA
Experimental: SaCo Video LMA (Group-V)
Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA
Procedure: SaCo Video LMA Group (Group-V)
Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal Leak Pressure
Time Frame: Periprocedural
The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful placement of the LMA on the first attempt
Time Frame: Periprocedural
Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement
Periprocedural
placement duration
Time Frame: Periprocedural
The placement duration will begin with the practitioner holding the patient's head with their left hand and holding the LMA in their right hand
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yil University

Investigators

  • Study Director: Şükran Sevimli, Assoc. Prof., Yuzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026/01-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol anda statistical analysis plan will be share with other researchers

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

The access can be provided via the e-mail addresses below emin6559@hotmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oropharengeal Leak Pressure

Clinical Trials on ProSeal LMA Group (Group-P)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe