ED90 of Tegileridine Combined With Propofol for LMA Insertion

Shiyou Wei109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

109

Conditions

Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response

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.

Time frame: Within 3 minutes after laryngeal mask airway insertion

Secondary Outcomes

Incidence of cough during laryngeal mask airway insertion

During anesthesia induction, intravenous injection of opioids may cause coughing.

Time frame: From the start of anesthesia induction to the end of anesthesia induction .

Success rate of sedation

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.

Time frame: From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion