Painless gastroscopy and colonoscopy in obese patients
Conditions
Interventions
Study phase 1: esketamine group:The initial dose of esketamine was 0.10 mg/kg, and the dose of esketamine for each subsequent subject was determined according to the modified sequential method with a
Study phase 1: remifentanil group:The initial dose of remifentanil was 0.10 µg/kg, and the dose of remifentanil for each subsequent subject was determined according to the modified sequential method w
Study phase 2: esketamine group:During induction, esketamine is administered first, with the dose determined after comprehensive evaluation based on the results from Phase 1. Following completion of a
Study phase 2: remifentanil group:During induction, remifentanil is administered first, with the dose determined after comprehensive evaluation based on the results from Phase 1. Following completion
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~65 years, any gender; 2. ASA physical status II–III; 3. 28 kg/m² <= BMI <= 37.5 kg/m²; 4. Scheduled for elective painless gastrointestinal endoscopy; 5. Voluntarily agree to participate in the study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Language, visual, hearing, psychiatric, psychological, or neurological disorders that preclude communication, informed consent, outcome assessment, or cooperation with the examination; 2. Cerebrovascular accident, myocardial infarction, unstable angina within the last 3 months, or severe hepatic or renal dysfunction; 3. Known or assessed high risk of difficult airway/ventilation (e.g. severe obstructive sleep apnea, history of difficult mask ventilation or difficult airway); 4. Allergy or contraindication to cipofol, esketamine, or remifentanil; 5. Use of opioid analgesics, sedative-hypnotics, or other centrally active drugs that may significantly affect sedation or respiratory assessment within 48 hours prior to enrollment; 6. Chronic pain or cancer pain requiring long-term use of analgesic medications; 7. Participation in another drug clinical trial within the last 3 months; 8. Expected examination duration exceeding 30 minutes; 9.Deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroscope placement reaction;Incidence of hypoxemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressure ;Heart rate;Pulse oxygen saturation;Cough response score ;Body movement response score;Procedure time;Recovery time;Discharge time;Endoscopist satisfaction;Patient satisfaction;Adverse events; | — |
Countries
China
Contacts
Public ContactChun Yang
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed