Endoscopic retrograde cholangiopancreatography (ERCP)
Conditions
Interventions
Experimental group:The initial dose of oliceridine fumarate is 20 µg/kg, and the rescue dose is 10 µg/kg.
Control group:The initial dose of Fentanyl citrate is 1 µg/kg, and the rescue dose is 0.5 µg/kg.
Sponsors
Tianjin Nankai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old and < 85 years old, 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 to undergo elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia while maintaining spontaneous respiration. (4) Agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have chronic pain and have been taking analgesics, psychotropic drugs for a long time, or are alcohol abusers; (2) Those with severe preoperative renal function abnormalities; (3) Those with a history of abnormal recovery from surgical anesthesia in the past; (4) Those suffering from esophageal reflux disease; (5) Those who have used sedatives, analgesics or antipruritic drugs within 24 hours before the operation; (6) Patients expected to have airway difficulties; (7) Those who have undergone liver surgeries; (8) Those with a history of opioid allergy; (9) Those who have taken monoamine oxidase inhibitor drugs or antidepressant drugs within fifteen days; (10) Those with a definite diagnosis of heart diseases (such as heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.), lung diseases (such as asthma, chronic obstructive pulmonary disease (COPD), pulmonary embolism, pulmonary edema or lung cancer), or central nervous system abnormalities; (11) Epileptic patients; (12) Pregnant women or women during lactation; (13) Those who have participated in other clinical studies within 3 months before enrollment; (14) Those who are unable 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 10 consecutive seconds;Memory and executive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of occurrences of hypoxia;Intervention measures after the occurrence of respiratory depression;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 and the time of recovery;Patient satisfaction;Endoscopists satisfaction;End-tidal carbon dioxide;Hemodynamics;respiratory rate;Analgesia Score;Early Postoperative Recovery Quality (QOR-15 Scale Score);nausea and vomiting;itch;somnolence;dizziness;headache;constipation;sports performance; attention; | — |
Countries
China
Contacts
Public ContactJianbo Yu
Tianjin Nankai Hospital
Outcome results
None listed