ED90 of Tegileridine Combined With Propofol for LMA Insertion

90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study

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 (18-65 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 Overview

• Status: Not yet recruiting
• Conditions: Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia
• Intervention / Treatment: Drug: Tegileridine combined with Propofol for anesthesia induction

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shiyou W Wei; Phone Number: +86 15601680288; Email: lovewishyou@tongji.edu.cn
• Study Contact Backup: Name: Jianmang Y Yu; Phone Number: +8613094293728; Email: yujianmang@hbust.edu.cn

Study Locations

• China
  • Hubei
    • Tianmen, Hubei, China, 431700
      • Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology
      • Contact: Jianmang Y Yu; Phone Number: +8613094293728; Email: yujianmang@hbust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Group (All Adult Patients Aged ≥18 Years); All enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg/kg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg/kg, with 1 μg/kg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-65 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects.

Drug: Tegileridine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 3 minutes after laryngeal mask airway insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cough during laryngeal mask airway insertion	During anesthesia induction, intravenous injection of opioids may cause coughing. During the after laryngeal mask airway insertion process, coughing may occur due to airway stimulation.	From the start of anesthesia induction to 3 minutes after the end of laryngeal mask airway insertion
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.	From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure at predefined time points	Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) are recorded at: Baseline (prior to tegileridine administration) ,2 minutes after tegileridine bolus, Immediately before laryngeal mask airway insertion, The highest values within 3 minutes following insertion	From baseline through 3 minutes after laryngeal mask airway insertion.
Heart rate at predefined time points	Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before laryngeal mask airway insertion, and the peak value within 3 minutes after insertion.	From baseline through 3 minutes after laryngeal mask airway insertion.
Incidence of perioperative adverse events	The proportion of participants with perioperative adverse reactions including hypotension, bradycardia, arrhythmia, palpitations, dizziness, hypersensitivity, nausea and vomiting, laryngospasm, pruritus, respiratory depression. All adverse events from anesthesia induction to 24 hours postoperatively will be recorded.	From anesthesia induction to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Shiyou Wei

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): August 9, 2026
• Study Completion (Estimated): August 10, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: laryngeal mask airway; ED90; µ-opioid receptor G-protein-biased agonist; Tegileridine; Biased-coin sequential allocation
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: tianmen20260016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No