ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy

Shiyou Wei107 enrolled

Overview

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 (18-64 years) and elderly (≥65 years) subgroups. All subjects receive intravenous tegileridine followed by 1-2 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 centered isotonic regression. Secondary outcomes include total propofol consumption, MOAA/S sedation score, blood pressure and heart rate changes, and incidence of perioperative adverse events within 24 hours post-procedure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Painless Gastroscopy Perioperative Sedation Upper Gastrointestinal Tract Lesions

Interventions

Tegileridine combined with Propofol for gastroscopyDRUG

All participants receive intravenous tegileridine with dose adjusted by biased-coin up-and-down sequential design, combined with fixed-dose propofol 1-2 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 (18-64 years) and elderly (≥65 years) subgroups for separate ED90 calculation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy

The 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol 1-2 mg/kg to fully suppress positive responses during gastroscopy insertion, calculated via centered isotonic 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 (18-64 years) and elderly (≥65 years) subgroups for separate ED90 estimation.

Time frame: Within 3 minutes after gastroscopy insertion

Secondary Outcomes

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

Time frame: 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.