Nausea and Vomiting, Postoperative, Sore-throat
Conditions
Keywords
Gastric insufflation, Ultrasound, Supraglottic airway devices, Oropharyngeal leak pressure
Brief summary
This study was planned to compare the gastric insufflation volume between i jel and ProSeal laryngeal mask airway (LMA) and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
Detailed description
Supraglottic airway devices (SADs) are widely used in both elective and emergency surgeries, resuscitation, and difficult airway management. Compared to endotracheal intubation, they are less invasive, require lower doses of anaesthetic agents, and cause less haemodynamic instability. Among supraglottic airway devices, the I-gel differs from other SADs in that it does not have an inflatable cuff; instead, it features a soft structure made of a transparent thermoplastic elastomer that mimics a cuff. In addition, it has a gastric channel alongside the airway tube that allows for gastric aspiration. ProSeal LMA is one of the most commonly used SADs in clinical practice. It was developed in the early 2000s as a modification of the classic LMA and includes an inflatable cuff. Like the I-gel, it also features a gastric drainage channel for aspiration. Aspiration pneumonia is a serious complication of anaesthesia, accounting for approximately 9% of all anaesthesia-related mortality. Traditionally, oropharyngeal leak pressure (OLP) provides information about the potential for gastric insufflation and thus the risk of gastric aspiration. Measurement of the gastric antral cross-sectional area (AGCA) by ultrasound allows for the estimation of gastric volume and helps assess the risk of aspiration. This study was planned to compare the gastric insufflation volume between i jel and ProSeal LMA and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
Interventions
OTHERi jel LMA
Patients will be inserted i jel laryngeal mask under general anesthesia.
OTHERproseal LMA
Patients will be inserted proseal laryngeal mask under general anesthesia.
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with an ASA (American Society of Anesthesiologists) physical status score of 1 to 3 * undergoing urological surgeries performed with I-gel or ProSeal LMA
Exclusion criteria
* Difficult airway * Clinically significant upper respiratory tract infection * Pre-existing airway disease * Pre-existing airway disease * History of head and neck surgery * Pregnant patients * Patients with upper gastrointestinal tract disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of oropharyngeal leak pressure (OLP) | Five minutes after successful LMA placement | One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric volume | 1 minute before induction of anesthesia | Before induction of anesthesia, gastric ultrasonography will be performed by an experienced anaesthesiologist using a 2-5 MHz curved-array probe. The gastric antrum will be visualised in the sagittal plane in the epigastric region, located between the left lobe of the liver anteriorly, the aorta or inferior vena cava inferiorly, and the pancreas posteriorly. The gastric cross-sectional area (CSA) will be calculated using the following formula, assuming the antrum is elliptical: CSA = (A × B × π) / 4, where A is the anteroposterior diameter and B is the craniocaudal diameter. The estimated gastric volume will be calculated using a previously validated model for non-pregnant adults: Estimated gastric volume (mL) = 27 + (14.6 × ACSA \[cm²\]) - (1.28 × Age \[years\]). |
| fiberoptic view grading | Five minutes after successful LMA placement | The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible. |
| Complications during i jel and propseal LMA removal (emerge) | One minute after i jel and propseal LMA removal | Complications during SP\_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| sore throat | popstoperative 1. hour | The presence or absence of sore throat will be recorded at the firsth postoperative hour. |
| dysphonia | popstoperative 1. hour | The presence or absence of dysphonia will be recorded at the firsth postoperative hour. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactZeynep Koç
Outcome results
None listed