ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy

ConditionsPainless Gastroscopy Perioperative Sedation Upper Gastrointestinal Tract Lesions

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorShiyou Wei

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Tegileridine combined with Propofol for gastroscopy
Drug
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.

Treatment groups

108 Participants

are divided into 1 treatment group

Group A: Single Group (All Adult Patients Aged ≥18 Years)Experimental treatment 1 intervention

Trial 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 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.

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.

Time frame

From baseline through 3 minutes after gastroscopy insertion.

Other outcomes

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.

Time frame

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

Time frame

From anesthesia induction to 24 hours after gastroscopy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shiyou Wei

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Source ClinicalTrials.gov

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