Biliary diseases
Conditions
Interventions
Experimental group:The initial dose of oxycodone is 0.08~0.1 mg/kg, and the rescue dose is 1/3 to 1/2 of the initial dose.
Control group:The initial dose of sufentanil is 0.1 µg/kg, and the rescue dose is 1/3 to 1/2 of the initial dose.
Sponsors
Tianjin Nankai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years and <80 years, with no restrictions on gender or ethnicity; 2.Body mass index (BMI) ranging from 18 to 30 kg/m², and American Society of Anesthesiologists (ASA) physical status classification of Grade I-III; 3.Patients scheduled for elective ERCP under anesthesia with spontaneous respiration retained; 4.Patients who provide informed consent to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with chronic pain on long-term analgesics, psychotropic drugs, or a history of alcohol abuse; 2.Severe hepatic or renal dysfunction; 3.A history of abnormal recovery from previous surgical anesthesia; 4.Suffering from gastroesophageal reflux disease (GERD); 5.Administration of sedatives, analgesics, or antipruritic drugs within 24 hours before surgery; 6.A history of hypersensitivity to oxycodone, propofol, or opioid drugs; 7.Anticipated difficult airway; 8.Use of monoamine oxidase inhibitors or antidepressants within 15 days; 9.Complicated with severe cardiac diseases (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.), pulmonary diseases (asthma, COPD, pulmonary embolism, pulmonary edema, or lung cancer), or central nervous system abnormalities; 10.Pregnant or lactating women; 11.Participation in other clinical trials within 3 months prior to enrollment; 12.Inability to communicate normally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion (%) of the need for artificial assisted ventilation when the blood oxygen saturation (SpO2) is lower than 90% for 5 consecutive seconds; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence times and duration of hypoxemia;Intervention measures after the occurrence of respiratory depression;Incidence of severe hypoxemia (SpO2= 85%);minimum SpO2 level;The number of times that endoscopic treatment was stopped halfway;The incidence rate of paroxysmal cough;The frequency and dosage of rescue medications;The time of awakening ;Patient satisfaction;Endoscopists satisfaction;Success rate of retrograde papillary intubation;End-tidal carbon dioxide;Hemodynamics;respiratory rate;Pain scores: Critical Care Pain Observation Tool (CPOT) during surgery; Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) at the end of surgery or postoperatively;Postoperative analgesic medication usage;Early Postoperative Recovery Quality (QOR-15 Scale Score);nausea and vomiting;itch;Flatus time;urinary retention;abdominal distension;constipation;dizziness and headache;the time of recovery; | — |
Countries
China
Contacts
Public ContactJjianbo Yu
Tianjin Nankai Hospital
Outcome results
None listed