Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia
Conditions
Keywords
Tegileridine, µ-opioid receptor G-protein-biased agonist, laryngeal mask airway, Biased-coin sequential allocation, ED90
Brief summary
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-64 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
Interventions
DRUGTegileridine combined with Propofol for anesthesia induction
Intravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg/kg for general anesthesia induction before laryngeal mask airway placement.
Sponsors
Shiyou Wei
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective surgery requiring general anesthesia with laryngeal mask airway insertion * Age ≥ 18 years * American Society of Anesthesiologists (ASA) physical status I-III
Exclusion criteria
* At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm * Continuous opioid medication for more than 2 weeks within half a year before surgery * Known allergy or hypersensitivity to tegileridine or any study medication components * History of psychiatric illness or inability to communicate effectively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response | Within 3 minutes after laryngeal mask airway insertion | The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure/heart rate increase over 20% compared with baseline within 3 minutes after LMA placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cough during laryngeal mask airway insertion | From the start of anesthesia induction to the end of anesthesia induction . | During anesthesia induction, intravenous injection of opioids may cause coughing. |
| Success rate of sedation | From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion | The modified observer's assessment of alert/sedation scale (MOAA/S) is a commonly - used sedation evaluation tool in clinical practice. It classifies reactivity under different stimuli: Grade 5 means a sensitive response to calling the name in a normal tone of voice; Grade 4 indicates a sluggish response to calling the name in a normal tone of voice; Grade 3 requires a loud or repeated call of the name to elicit a response; Grade 2 shows a response to slight pushing and vibration; Grade 1 has a response to a painful stimulus (by squeezing the trapezius muscle area); Grade 0 means no response to a painful stimulus. Moreover, MOAA/S ≤ 2 indicates loss of consciousness, which can assist medical staff in judging the sedation level and consciousness state of patients. |
Countries
China
Outcome results
None listed