Pain
Conditions
Interventions
Sufentanil group (S group):Sufentanil (0.1 µg/kg) combined with propofol (1.5 mg/kg)
Sponsors
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients scheduled to undergo gastroscopy under intravenous anesthesia; 2. Aged between 18 and 65 years (inclusive); 3. Classified as American Society of Anesthesiologists (ASA) Physical Status I–II; 4. Estimated procedure duration within 20 minutes; 5. Provided written informed consent and voluntarily agreed to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) > 35 kg/m^2; 2. Diagnosed with obstructive sleep apnea; 3. History of allergy to opioids or any contraindications to opioid use; 4. Chronic opioid therapy (defined as >15 morphine milligram equivalents [MME] per day, >3 days per week, for >1 month within the year prior to the procedure); use of any analgesics within 5 elimination half-lives prior to the procedure (or within 48 hours if half-life is unknown); long-term NSAID therapy (defined as daily use >2 weeks within the 6 months prior to the procedure, excluding patients on stable aspirin therapy =30 days for cardiovascular prevention); 5. Oral or parenteral corticosteroids or medications that may affect pain perception (including centrally acting alpha-adrenergic agents, antiepileptics, neuroleptics, antidepressants, or antipsychotics) within the past 3 months, unless the dosage has been stable for >=30 days; 6. Severe respiratory insufficiency (defined as respiratory failure: PaO2/FiO2 ratio [RFI] 6.67 kPa [50 mmHg]); 7. Evidence of subclinical respiratory depression prior to the procedure; 8. Abnormal electrocardiogram (QTcF interval >470 ms at screening), or known hepatic or renal disease; 9. Inability to comply with the study for any reason, including language barriers, psychiatric conditions, or logistical inability to attend follow-up visits; 10. Any condition deemed by the investigator to make the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypoxemia during gastroscopy (75%<=SpO2<90%,<60 s); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of subclinical respiratory depression (90%<=SpO2 <95%);Incidence of severe hypoxemia (SpO2 <75%, or SpO2 <90% lasting more than 60 seconds);Dosage of sedative agent propofol;ccurrence of nausea during endoscope insertion;Respiratory depression assessment: SpO? levels recorded at room entry (T0), 1 minute after induction (T1), 5 minutes after induction (T2), and after cessation of oxygen in PACU (T3);Use of antiemetic medications in the PACU;Patient satisfaction with anesthesia experience during gastroscopy;Patient fatigue score in the PACU;Patient length of stay in the PACU;MOAA/S score at hospital discharge;Endoscopist satisfaction; | — |
Countries
China
Contacts
Public ContactXiao Shi ; Ye Liu
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Outcome results
None listed