colorectal cancer
Conditions
Interventions
Tegileridine group:A modified Dixon's up-and-down sequential method was employed, starting with an initial tegileridine dose of 15 µg/kg and a dose ratio of 1:1.1 between consecutive patients. Patient
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old <= age <=65 years old in-patients with colorectal cancer surgery, both men and women; 2. Patients undergoing elective laparoscopic colorectal cancer surgery under general anesthesia who are expected to require 48-hour postoperative patient-controlled intravenous analgesia (moderate or severe pain) ; 3. General anesthesia tracheal intubation, ASA Anesthesia Class I-III; 4. 18.5 kg/m^2<= body mass index < 30 kg/m^2; 5. Subjects fully understand the purpose, content, procedure, and risks of the trial and voluntarily participate in the clinical trial with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications to the use of tiagilidine fumarate (e.g. known or suspected intestinal obstruction, severe respiratory depression-patients with oxygen saturation below 90% in inhaled air) ; 2. Dependence on opioids and other analgesics; use of opioid agonists/antagonists within 24 h before surgery (or within 5 half-lives of drug instructions) ; Or other medications/treatments that may affect the analgesic effect, including but not limited to NSAIDs, opioids, pregabalin, sedatives, etc. ; 3. With severe cardiovascular disease-within the first 6 months, the following cardiovascular events occurred: acute coronary syndrome, coronary artery bypass grafting, percutaneous coronary intervention (except diagnostic angiography) , heart failure (New York Heart Association [ NYHA ] Class III or IV ] , severe or requiring treatment arrhythmia, cerebrovascular accident (including Tia) ; 4. Patients with severe respiratory disease (i.e. severe asthma, chronic obstructive pulmonary disease, pulmonary heart disease, oxygen saturation below 90%) ; 5. Presence of hepatic or renal dysfunction (any of the following abnormalities in our laboratory screening values: ALT and/or AST > 2 times the upper limit of normal, BUN > 2 times the upper limit of normal, or CR > the upper limit of normal) ; 6. Patients with severe central nervous system disease or definite mental illness, or who are unable to understand and cooperate with pain scores; 7. Patients with abnormal coagulation function, these included patients with congenital bleeding disorders (e.g. , hemophilia) , thrombocytopenia (platelet count below 80 × 109L) , Coagulopathy (PT prolongation exceeding the upper limit of normal by 3 s or APTT prolongation exceeding the upper limit of normal by 10 s) , or a history of diseases related to abnormal platelet function; 8. Patients who are allergic to the drugs involved in this study or who have other contraindications; 9. Patients who participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic dose of tapentadol fumarate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of drug-related adverse reactions;NRS Score;The usage rate, frequency, and dosage of painkillers;Number of effective presses and drug consumption; | — |
Countries
China
Contacts
Public ContactBo Lulong
Shanghai Changhai Hospital
Outcome results
None listed