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To compare of oropharyngeal leak pressures of SaCo video laryngeal mask airway (LMA) and ProSeal LMA in adult elective surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProSeal LMA (Group-P) | Active Comparator | Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA |
|
| SaCo Video LMA (Group-V) | Experimental | Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProSeal LMA Group (Group-P) | Procedure | Group-P: ProSeal LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a ProSeal LMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal Leak Pressure | The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Successful placement of the LMA on the first attempt | Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement | Periprocedural |
| placement duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Şükran Sevimli, Assoc. Prof. | Yuzuncu Yil University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University | Van | Tusba | 65100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20540172 | Background | Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3. | |
| 24145803 | Background | Maitra S, Khanna P, Baidya DK. Comparison of laryngeal mask airway Supreme and laryngeal mask airway Pro-Seal for controlled ventilation during general anaesthesia in adult patients: systematic review with meta-analysis. Eur J Anaesthesiol. 2014 May;31(5):266-73. doi: 10.1097/01.EJA.0000435015.89651.3d. |
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Study protocol anda statistical analysis plan will be share with other researchers
1 year
The access can be provided via the e-mail addresses below emin6559@hotmail.com
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180 adult patients scheduled for surgery will be randomly divided into two groups. After anesthesia, airway patency will be maintained in one group with a SaCo Video LMA and in the other group with a ProSeal LMA.
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| SaCo Video LMA Group (Group-V) | Procedure | Group-V: SaCo Video LMA group (n:90). in adult patients scheduled for surgery, airway patency will be maintained with a SaCo LMA |
|
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 |
| 40610857 | Background | Ozden GG, Dost B, Kaya C, Turunc E, Koksal E, Ustun YB, Bilgin S, Baris S. Comparison of oropharyngeal leak pressure between the SaCoVLM video laryngeal mask and LMA supreme in adult elective surgery patients: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jul 3;25(1):334. doi: 10.1186/s12871-025-03218-4. |