Painless Gastroscopy Perioperative Sedation, Upper Gastrointestinal Tract Lesions
Conditions
Keywords
Tegileridine, µ-opioid receptor G-protein-biased agonist, Biased-coin sequential allocation, gastroscopy, ED90
Brief summary
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.
Interventions
DRUGTegileridine 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 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.
Sponsors
Shiyou Wei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy | Within 3 minutes after gastroscopy insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure at predefined time points | From baseline through 3 minutes after gastroscopy insertion. | 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 |
| Heart rate at predefined time points | From baseline through 3 minutes after gastroscopy insertion. | 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. |
Countries
China
Outcome results
None listed