Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Tianmen, Hubei, 431700, China
Not Yet Recruiting
NCT Number: NCT07678411
ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Tegileridine combined with Propofol for gastroscopy
DrugAll 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.
Primary outcomes
-
90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy
Time frame: Within 3 minutes after gastroscopy insertion
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.
Secondary outcomes
-
Changes in blood pressure at predefined time points
Time frame: 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
Time frame: 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.
Other outcomes
-
Success rate of sedation
Time frame: 2 minutes after intravenous anesthetic injection
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.
-
Incidence of perioperative adverse events
Time frame: From anesthesia induction to 24 hours after gastroscopy
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shiyou Wei
Other
Registry information
Official study title
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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 1, 2026
- Registry last updated
- Jul 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.