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ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy

NCT07678411 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Painless Gastroscopy Perioperative Sedation
  • Upper Gastrointestinal Tract Lesions

Interventions

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 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 & Collaborators

  • Shiyou Wei

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-07-23
Completion
2026-07-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678411 on ClinicalTrials.gov