ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy

Determination of The 90% Effective Dose of Tegileridine Combined With Propofol for Gastroscopy in Patients of Different Ages: A Biased-Coin Up-and-down Design Study

This single-group, open-label, biased-coin up-and-down sequential dose-finding trial aims to determine the 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol to eliminate body movement, cough and excessive hemodynamic fluctuations during gastroscopy insertion in adult patients stratified into young (18-65 years) and elderly (≥65 years) subgroups. All subjects receive intravenous tegileridine followed by 2 mg/kg propofol for sedation induction. The initial tegileridine dose is 5 μg/kg with a 1 μg/kg dose step. Dose adjustment follows biased-coin algorithm: dose increases by 1 μg/kg if positive response occurs; if negative response, there is an 11% probability to decrease dose by 1 μg/kg. The trial will be terminated when 45 successful cases are accrued in each age subgroup. Primary outcome is ED90 of tegileridine calculated via central ordinal regression. Secondary outcomes include total propofol consumption, MOAA/S sedation score, intraoperative blood pressure and heart rate changes, and incidence of perioperative adverse events within 24 hours post-procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Painless Gastroscopy Perioperative Sedation; Upper Gastrointestinal Tract Lesions
• Intervention / Treatment: Drug: Tegileridine combined with Propofol for gastroscopy

• 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; 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 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:

• Outpatients scheduled for elective painless gastroscopy
• Age ≥ 18 years old
• American Society of Anesthesiologists (ASA) physical status I-III
• Body mass index (BMI) between 18.5 and 29.9 kg/m²

Exclusion Criteria:

• Resting SBP ≥ 160 mmHg, DBP ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to endoscopy room
• Continuous opioid medication use for more than 2 weeks within 6 months before the procedure
• Known hypersensitivity or allergic reaction to tegileridine, propofol or any excipients of the two drugs
• Diagnosed psychiatric disorders or inability to communicate and cooperate with study assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group 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 receive variable-dose intravenous tegileridine adjusted by biased-coin up-and-down sequential design plus fixed-dose propofol 2 mg/kg for sedation during painless gastroscopy. Patients are stratified into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 analysis.

Drug: Tegileridine combined with Propofol for gastroscopy; All participants receive intravenous tegileridine with dose adjusted by biased-coin up-and-down sequential design, combined with fixed-dose propofol 2 mg/kg for anesthesia induction before painless gastroscopy. The initial dose of tegileridine is 5 μg/kg, with a 1 μg/kg step for dose increment or decrement according to gastroscopy insertion response. Subjects are stratified into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 calculation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy	The 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol 2 mg/kg to fully suppress positive responses during gastroscopy insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as body movement, cough, or blood pressure/heart rate elevation exceeding 20% compared with baseline within 3 minutes after gastroscopy placement. Subjects are divided into young (18-65 years) and elderly (≥65 years) subgroups for separate ED90 estimation.	Within 3 minutes after gastroscopy insertion

Secondary 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 gastroscopy insertion, The highest values within 3 minutes following insertion	From baseline through 3 minutes after gastroscopy insertion.
Heart rate at predefined time points	Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before gastroscopy insertion, and the peak value within 3 minutes after insertion.	From baseline through 3 minutes after gastroscopy insertion.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 minutes after intravenous anesthetic injection
Incidence of perioperative adverse events	Proportion of participants experiencing adverse events including hypotension, bradycardia, arrhythmia, palpitations, dizziness, hypersensitivity, nausea and vomiting, respiratory depression during sedation and within 24 hours after gastroscopy	From anesthesia induction to 24 hours after gastroscopy

Collaborators and Investigators

• Sponsor: Shiyou Wei

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): July 27, 2026

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: gastroscopy; ED90; µ-opioid receptor G-protein-biased agonist; Tegileridine; Biased-coin sequential allocation
• Additional Relevant MeSH Terms: Organic Chemicals; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Propofol; Gastroscopy
• Other Study ID Numbers: 20260254

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