Oropharengeal Leak Pressure
Conditions
Keywords
oropharengeal leak pressure, laryngeal masks
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.
Interventions
PROCEDUREProSeal 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
PROCEDURESaCo 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
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure | Periprocedural | The oropharengeal leak pressure will be evaluated by same anaesthetist after LMA placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful placement of the LMA on the first attempt | Periprocedural | Successful placement will be assessed by observing a continuous trace of end tidal CO2 after LMA placement |
| placement duration | 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 |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORŞükran Sevimli, Assoc. Prof.
Yuzuncu Yil University
Outcome results
None listed