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Clinical Trials/NCT07688590
NCT07688590Active, not recruitingNot Applicable

Van Yuzuncu Yil University Faculty of Medicine Ethics Committee

Yuzuncu Yil University1 site in 1 country180 target enrollmentStarted: February 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
Oropharyngeal Leak Pressure

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Oropharyngeal Leak Pressure

Time Frame: Periprocedural

The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement

Secondary Outcomes

  • Successful placement of the LMA on the first attempt(Periprocedural)
  • placement duration(Periprocedural)

Investigators

Sponsor
Yuzuncu Yil University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Emin Keskin

Assistant Professor

Yuzuncu Yil University

Study Sites (1)

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