Sore-throat
Conditions
Brief summary
This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Detailed description
Laryngeal mask and tracheal intubation are the two most commonly used airway management methods for patients under general anesthesia. Compared with tracheal intubation, laryngeal mask has the advantages of simple insertion, less airway injury, and more stable hemodynamics. Therefore, laryngeal mask has been widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the British National Health Service system receive anesthesia surgery with different types of airway management every year, and the usage rate of laryngeal mask is higher than that of tracheal intubation, accounting for about 56.2%. Many new laryngeal masks have been improved based on the classic laryngeal mask and applied to clinical practice. Currently, there are two main types of laryngeal masks: inflatable laryngeal masks and non-inflatable laryngeal masks. Inflatable laryngeal masks are traditional types, including BlockBuster, Superme, ProSeal, and Fastrach, which are the most widely used in clinical practice. Traditional laryngeal masks require inflation to achieve sealing of the throat opening, but inflatable laryngeal masks have drawbacks such as inconvenient insertion, higher incidence of oral and pharyngeal injury and bleeding, and a higher incidence of postoperative sore throat. According to report, the incidence of postoperative sore throat with laryngeal masks is up to 31.9%. The non-inflatable laryngeal mask is mirrored at the throat opening and made of thermoplastic elastomer material, which achieves a gas tightness effect similar to the inflatable laryngeal mask, improves the ease of insertion, and reduces complications such as sore throat and mucosal injury and bleeding. The i-gel laryngeal mask is the most commonly used non-inflated laryngeal mask currently. A meta-analysis found that the incidence of postoperative sore throat with the i-gel laryngeal mask is 4.1%, which is significantly lower than that of inflatable laryngeal masks. GMA-TULIP is a new type of non-inflatable laryngeal mask with advantages such as C-shaped double gastric tube channel, stable platform for tongue root, soft tissue sealing ring, epiglottis attached protrusion, and consistent with the anatomical structure of the throat. In addition, the front cuff of GMA-TULIP is small, which only needs to reach the two sides of the pyriform fossa in the distal end. During placement, it passes over the tongue root and reaches the standard position. Compared with i-gel non-inflatable laryngeal mask, GMA-TULIP is more in line with the anatomical position design, theoretically better in position, less likely to cause damage to the throat and pharynx, thus, lower incidence of postoperative sore throat. In laparoscopic surgeries with trendelenburg position under general anesthesia, the airway pressure is significantly higher than that in the supine position and non-laparoscopic surgery, thus, the incidence of postoperative sore throat is higher than that in the supine position and non-laparoscopic surgery. Therefore, this project intends to compare the effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask, and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Interventions
DEVICEGMA-TULIP
Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours. 2. Ages between 18 to 80, and body mass index less than 28 kg/m². 3. American Society of Anesthesiologists (ASA) Grades I-III. 4. Patients are willing to participate and be able to understand and sign an informed consent form.
Exclusion criteria
1. Patients with a mouth opening less than 2 cm. 2. Patients with risk factors for regurgitation and aspiration of gastric contents. 3. Patients with laryngopharyngeal diseases. 4. Patients with potentially difficult airways. 5. Patients with hearing, intellectual, communication, and cognitive impairments. 6. Any reason that patients could not cooperate with the study or that the researcher deems inappropriate for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative sore throat | 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery | Sore throat is assessed by Prince-Henry pain scores (0 to 4 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of dysphagia | 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery | Check the patient can swallow or not |
Other
| Measure | Time frame | Description |
|---|---|---|
| Times of laryngeal mask adjustment before the successful insertion | 1 min after the airway is successfully controlled. | The times of laryngeal mask adjustments before successful laryngeal mask insertion. |
| The rate of first-insertion success | 1 min after the first-attempt insertion of the laryngeal mask | The first successful insertion is defined as oropharyngeal leak pressure higher than 20 cmH2O and grade 1-2 of the laryngeal view under the fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning) at the first attempt. |
| Total insertion success rate | 1 min after the airway is successfully controlled. | The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction. |
| Success rate of gastric tube insertion through laryngeal mask | 1 min after the laryngeal mask is successful inserted | After the laryngeal mask is successful inserted, a fully lubricated 14F gastric tube was inserted through its esophageal drainage tube |
| grade of view on fibreoptic bronchoscopy | 1 min after successful insertion of the laryngeal mask, 5 min after pneumoperitoneum and trendelenburg position | After successful insertion of the laryngeal mask, fiberoptic bronchoscopy was used and graded according to the degree of glottic and epiglottis exposure by a 4-point scale system: 1, full view of glottis; 2, vocal cords, arytenoids, and inferior surface of epiglottis visible; 3, only superior surface of epiglottis visible; 4, no part of epiglottis or larynx visible. The grades 1 and 2 were defined as optimal fiberscopic view. |
| diastolic blood pressure | 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn | diastolic blood pressure |
| oropharyngeal leak pressure | 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position | After the laryngeal mask is inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, and listen to the neck until the sound of air leakage is heard. The peak airway pressure at this time is the oropharyngeal leak pressure. |
| Peak airway pressure | 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position | Peak pressure refers to the maximum pressure produced by the airflow in the closed circuit each time the ventilator delivers a certain amount of gas from the endotracheal tube to the patient's lungs. Peak airway pressure was measured by the anesthesia machine automatically. |
| Airway plateau pressure | 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position | Plateau airway pressure refers to the pressure that a certain amount of gas remains in the lungs against the entire closed system at the end of the passage of air, before the beginning of exhalation. Airway plateau pressure was measured by the anesthesia machine automatically. |
| systolic blood pressure | 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn | systolic blood pressure |
| heart rate | 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn | heart rate |
| Times of intraoperative air leakage | From the start of anesthesia to the end of the anesthesia | intraoperative air leakage is defined as hearing an air leak in the pharynx during the operation |
| Times of laryngeal mask adjustment during the operation | From the start of anesthesia to the patient's exit from the operating room | the times of the laryngeal mask adjustment during the operation were recorded |
| The incidence of aspiration | From the start of anesthesia to the patient's exit from the operating room | The aspiration is defined as seeing the gastric content in the trachea |
| The incidence of regurgitation | From the start of anesthesia to the patient's exit from the operating room | The regurgitation is defined as seeing the gastric content in the mouth |
| incidence of blood staining on the laryngeal mask | 1 min after the laryngeal mask is pull out after surgery. | When the laryngeal mask was pulled out, the laryngeal mask was stained with blood |
| The incidence of cough | the time when the laryngeal mask is pull out | When the laryngeal mask was pulled out, record whether the patient has cough or not. |
| Active mouth bleeding rate | 1 min after laryngeal mask removal | After the laryngeal mask was removed, record whether active bleeding occurred at the patient's mouth |
| Time of laryngeal mask application | 1 min after the laryngeal mask is withdrawn | The time of laryngeal mask withdrawn minus the time of successful laryngeal mask insertion is the time of laryngeal mask application |
| Length of surgery | 1 min after the end of surgery | The end of the surgery time minus the start of the surgery time is the length of surgery |
| The incidence of hoarseness | 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery | the patient is hoarse when speaking |
| mean arterial pressure | 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn | mean arterial pressure |
| Time of insertion | 1 min after successful insertion of the laryngeal mask | Insertion time was defined as the time from the opening of the mouth by the operator to the positively insert the laryngeal mask. The time of glottic examination, adjustment between two ventilation insertions, and ventilation was not measured as ventilation insertion time. |
Countries
China
Contacts
Primary ContactBing Chen, PhD
Outcome results
None listed