Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04719767
Status:
UNKNOWN
Last Update Posted:
2021-01-25
First Post:
2021-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in General Anesthesia
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in Non-head and Neck Surgery Under General Anesthesia
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the advantages of visual laryngeal mask combined with endotracheal intubation in general anesthesia surgery, we compared intubation time, intubation times and intubation success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions, at the same time, the laryngeal mask displacement rate, volume of secretion in airway, the incidence of laryngeal spasm, the incidence and severity of postoperative oropharyngeal pain were also compared between two groups.
Detailed Description:
After entering the operating room, the patient received routine general anaesthesia monitoring, and anesthesia induction was conducted after three-party verification. Propofol (plasma target-controlled concentration: 3.5ug/ mL), midazolam (0.05mg/kg), fentanyl (2ug/kg) and rocuronium (0.6mg/kg) were used to induce the drugs.
After anesthesia induction, visual laryngeal mask airway was placed in the visual group and endotracheal intubation was guided under visual conditions. In the non-visual group, after judging the position of laryngeal mask by clinical experience, endotracheal intubation was inserted blindly. Selection of laryngeal mask airway (LMA) model based on: the ideal body weight of the patient, 3 was selected for the body weight of 30-50kg, 4 for the body weight of 50-70kg and 5 for the body weight \> 70kg. The endotracheal tube intubation time, intubation times and intubation success rate of the two groups were recorded.
During the operation, propofol and fentanyl are used for anesthesia maintenance, and the anesthesiologist adjusts the anesthesia depth according to his/her own experience. Ten minutes before the end of the operation, endotracheal intubation was removed and the laryngeal mask airway was retained. The displacement rate of the laryngeal mask airway, the volume of secretion in airway and the incidence of laryngeal spasm were compared between the two groups.
After the surgery, the residual muscle relaxation was antagonized, and the laryngeal mask was removed after the patient regained consciousness and reached the extubation criteria. The hemodynamic parameters and the severity of cough during laryngeal mask airway removal were recorded. The incidence and severity of oropharyngeal pain, oropharyngeal numbness, hoarseness, nausea, and vomiting were assessed immediately after the patient woke up and was followed up before leaving the recovery room and on the first day after surgery.
After anesthesia induction, visual laryngeal mask airway was placed in the visual group and endotracheal intubation was guided under visual conditions. In the non-visual group, after judging the position of laryngeal mask by clinical experience, endotracheal intubation was inserted blindly. Selection of laryngeal mask airway (LMA) model based on: the ideal body weight of the patient, 3 was selected for the body weight of 30-50kg, 4 for the body weight of 50-70kg and 5 for the body weight \> 70kg. The endotracheal tube intubation time, intubation times and intubation success rate of the two groups were recorded.
During the operation, propofol and fentanyl are used for anesthesia maintenance, and the anesthesiologist adjusts the anesthesia depth according to his/her own experience. Ten minutes before the end of the operation, endotracheal intubation was removed and the laryngeal mask airway was retained. The displacement rate of the laryngeal mask airway, the volume of secretion in airway and the incidence of laryngeal spasm were compared between the two groups.
After the surgery, the residual muscle relaxation was antagonized, and the laryngeal mask was removed after the patient regained consciousness and reached the extubation criteria. The hemodynamic parameters and the severity of cough during laryngeal mask airway removal were recorded. The incidence and severity of oropharyngeal pain, oropharyngeal numbness, hoarseness, nausea, and vomiting were assessed immediately after the patient woke up and was followed up before leaving the recovery room and on the first day after surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: