postoperative acute pain in patients undergoing laparoscopic hepatectomy
Conditions
Interventions
Exploratory group:Anruikefon 100 µg per dose
Experimental group:Anruikefon 1 µg/kg/dose
Sponsors
Sun Yat-sen Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years; 2.American Society of Anesthesiologists (ASA) physical status classification I–III; 3.Body mass index (BMI): 18 kg/m² <= BMI <= 30 kg/m²; 4.Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration <= 5 hours; 5.Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History or evidence of any of the following conditions prior to screening: a) Severe cardiopulmonary disease (myocardial infarction, heart failure, or respiratory failure) b) History of neurological or psychiatric disorders: traumatic brain injury, intracranial hypertension, schizophrenia, mania, etc., which, as assessed by the investigator, render the subject unsuitable for participation in the study; c) History of gastrointestinal disorders: intestinal obstruction or other gastrointestinal disorders that the investigator determines may cause nausea or vomiting; or a history of other gastrointestinal disorders deemed unsuitable for study participation by the investigator; d) History of marked, chronic dizziness, or a clearly diagnosed vestibular disorder other than motion sickness (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.); 2.Patients undergoing emergency surgery or trauma patients; 3.Intraoperative conversion to open laparotomy; 4.History of abdominal surgery within the past 3 months; 5.Patients undergoing liver transplantation or with metastasis to other organs; 6.Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs; 7.Severe renal dysfunction (estimated glomerular filtration rate = Grade 3 per CTCAE v6.0; 9.Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation); 10.Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours; 11.Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial. 12.Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects. 13.Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consumption of sufentanil via PCIA within 48 h after the first study drug administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of rescue analgesia and cumulative consumption dose within 0–24 h and 0–48 h after the first study drug administration;Time from the end of surgery to recovery of intestinal function (defined as the first passage of flatus or first defecation, unit: hours);Incidence of nausea, vomiting and PONV within 48 hours after the first study drug administration;Patient satisfaction score for analgesia within 48 h after the first study drug administration;Proportion of subjects with resting NRS score = 3 within 0–24 h and 0–48 h after the first study drug administration;Resting and movement-evoked NRS scores (overall pain) at 1 h (±30 min), 8 h (±2 h), 24 h (±2 h), and 48 h (±3 h);Time from the end of surgery to first ambulation (unit: hours);Incidence and cumulative dose of rescue antiemetic treatment within 48 h after the first study drug administration;Incidence of serious adverse events and study drug-related adverse events during the treatment period;Richards-Campbell Sleep Questionnaire score on the night of surgery;Consumption of sufentanil via PCIA within 24 h after the first study drug administration;Biomarker levels within 24–48 h after the first study drug administration and their changes from baseline preoperative levels (ALT, AST, ALB, TBIL, DBIL, IBIL, INR, etc.);Proportion of subjects with movement-evoked NRS score = 3 within 0–24 h and 0–48 h after the first study drug administration;Overall quality of recovery assessed with the QoR-15 scale within 48 h after the first study drug administration;Cumulative opioid consumption within 0–24 h and 0–48 h after the first study drug administration (expressed as intravenous morphine milligram equivalents [MME]); | — |
Countries
China
Contacts
Public ContactShang Changzhen
Sun Yat-sen Memorial Hospital
Outcome results
None listed