Patients presenting with gastrointestinal discomfort or undergoing routine physical examinations.
Conditions
Interventions
Remifentanil group (Part 2 trial):Single intravenous dose of remifentanil at ED95 + propofol 1.25–1.75 mg/kg (additional 0.5 mg/kg if needed)
Sufentanil S group (Part 2 trial):Single intravenous dose of sufentanil at ED95 + propofol 1.25–1.75 mg/kg (additional 0.5 mg/kg if needed)
Fentanyl F group (Part 2 trial):Single intravenous dose of fentanyl at ED95 + propofol 1.25–1.75 mg/kg (additional 0.5 mg/kg if needed)
Sufentanil S group (Part 1 trial):Single intravenous dose of fentanyl (initial dose: 0.02 µg/kg, adjusted by BCD sequential method), followed by bolus injection of propofol 1.25–1.75 mg/kg (infusion r
Fentanyl F group (Part 1 trial):Single intravenous dose of fentanyl (initial dose: 0.2 µg/kg, adjusted by BCD sequential method), followed by bolus injection of propofol 1.25–1.75 mg/kg (infusion rate
Remifentanil group (Part 1 trial):Single intravenous dose of remifentanil (initial dose: 0.1 µg/kg, adjusted by BCD sequential method), followed by bolus injection of propofol 1.25–1.75 mg/kg (infusio
Sponsors
Zigong Fourth People's Hospital(Zigong First-aid Center)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Subjects scheduled to undergo painless gastroscopy; 2.Aged 18 to 60 years; 3.Body mass index (BMI) 18.5<=BMI<24 kg/m^2; 4.American Society of Anesthesiologists (ASA) physical status classification I-II; 5.No history of smoking;
Exclusion criteria
Exclusion criteria: 1. History of metabolic diseases with moderate to severe cardiac, cerebral, pulmonary, hepatic, renal, or cortical dysfunction; 2. History of upper gastrointestinal or respiratory tract surgery, reflux esophagitis, gastric retention, or delayed gastric emptying; 3. Previous history of abnormal recovery from surgical anesthesia; 4. Electrocardiogram indicating clinically significant arrhythmias, including but not limited to marked bradycardia (heart rate 100 beats/min); 5. History of asthma or airway hypersensitivity with respiratory infection within the past 2 weeks; 6. Anemia; 7. Hypertension with systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg before examination, or hypotension with blood pressure < 90/60 mmHg; 8. History of neuromuscular or psychiatric disorders; 9. Suspected abuse of narcotic analgesics or sedatives; 10. History of alcoholism; 11. Pregnant or lactating women; 12. Known allergy to emulsions or opioids. 13. Exclusion Criterion: Subjects Presenting with Any of the Following Airway-Related Risks 1. Predictors of Difficult Airway: Anthropometric Indicators: Modified Mallampati classification of III or IV. Inter-incisor distance (mouth opening) < 3 cm. Thyromental distance < 6 cm or reduced mentohyoid distance. Positive Upper Lip Bite Test. Inability to protrude the mandible anteriorly (Class C mandibular protrusion). Micrognathia. Increased neck circumference with a short neck morphology. Limited Cervical Spine Mobility: Active head extension (neck extension) angle < 35°. Cervical spine rotation < 60°. Comorbid conditions restricting cervical spine movement (e.g., rheumatoid arthritis, ankylosing spondylitis, history of cervical spine trauma or surgery). History of radiotherapy involving the head and neck region. 2. Risk of Upper Airway Stenosis or Obstruction: Fixed Anatomical Obstruction: Known pathologies leading to anatomical airway narrowing, including but not limited to: macroglossia, hypertrophic tonsils, laryngeal or glottic masses, airway scar contractures, as well as cervical scars, masses, or deformities with the potential to compromise the airway.Dynamic Airway Collapse: A confirmed diagnosis of Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). 3. Associated Syndromes: Syndromes with a known association to difficult airway management or anatomical airway narrowing, such as Pierre-Robin sequence and Down syndrome (particularly with concomitant atlantoaxial instability).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gastroscope insertion reaction (Primary Outcome of Phase I Trial);DSST Score (Primary Outcome of Phase II Trial) (only recorded for Part II of the trial); | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate (HR), Oxygen saturation (SpO2), End-tidal carbon dioxide (ETCO2), Mean arterial pressure (MAP);Incidence of jaw thrust and incidence of manual mask ventilation;Respiratory depression, hypotension, hypertension, tachycardia, bradycardia;15 Items quality of recovery,QOR-15 (only recorded for Part II of the trial);Duration of Dizziness;Area under the curve of oxygen desaturation,AUCDesat;Emergence Time;Nausea and vomiting;Duration of anesthesia;Incidence of injection pain (only recorded for Part II of the trial);PACU length of stay;Postoperative Fatigue Syndrome, POFS (only recorded for Part II of the trial); | — |
Countries
China
Contacts
Public ContactYu Gu
Zigong Fourth People's Hospital(Zigong First-aid Center)
Outcome results
None listed