Injection de citrate de mosapride pour la dysfonction gastrointestinale postopératoire

Date de début de l'étude : 18 octobre 2024

Inclusion Criteria: 1）Voluntary participation and signing of informed consent; 2\) Aged ≥18 years and ≤75 years and BMI≤28kg/m2, regardless of gender; 3\) Patients undergoing elective laparoscopic-assisted intestinal resection and the surgical site is part of the intestinal segment from the ileocecal region to the sigmoid colon; 4\) Vital organ functions meet the following requirements:iver function: ALT and AST≤3×ULN, total bilirubin level≤2×ULN; Renal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance≥50mL/min (when Cr\>1.5×ULN); Blood routine examination: hemoglobin (HGB)≥80g/L; Blood biochemistry: albumin (ALB)≥30g/L; 5\) Those classified as physical condition 1 to 3 by the American Society of Anesthesiologists (ASA). Exclusion Criteria: 1\) Patients with a history of clinically significant drug allergy or known allergy to the study drug ingredients and excipients; 2）Those who have a history of severe heart, lung, liver, kidney, blood, endocrine, immune, skin, neurological or mental diseases in the past two years or currently have diseases of the above systems; 3\) Those with a history of drug abuse in the past 6 months; 4\) Those with a history of constipation in the past 6 months (less than 3 bowel movements per week); 5\) Severe mechanical intestinal obstruction that is not expected to be relieved after surgery, short bowel syndrome, significant gastrointestinal motility disorders (such as gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), poorly controlled Those with diabetes (HbA1c\>8.5%) or gastrointestinal pacemakers installed in their bodies; 6\) Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) and intestinal adhesions; 7\) Those who have undergone major abdominal surgery (such as gastrectomy, gastric bypass, sleeve gastrectomy, gastric band surgery, Whipple surgery, pancreatectomy, colectomy, hemicolectomy); 8\) QTcF interval: ≥450 milliseconds for men and ≥470 milliseconds for women (the QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]); 9\) Patients who received chemotherapy within 4 weeks before surgery; 10\) Those who are scheduled for emergency surgery or undergo any of the following surgeries: appendectomy, low anterior resection, colostomy, ileostomy, or stoma reversal, or diagnosed with needing proctocolectomy/low anterior resection Subjects whose disease may cause impaired rectal function or postoperative incontinence (except for lesions that do not involve the sigmoid colon and above); 11\) Within 3 days before the first dose, patients had received stimulants such as alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride or azithromycin. Gastrointestinal motility drugs; 12\) Pregnant or lactating women, as well as those who plan to become pregnant or donate sperm or eggs during the study period and within 3 months after the end of the study, and are unwilling to use a medically recognized contraceptive measure (such as intrauterine contraceptive device or contraceptive) during the study period. sets); 13\) Participated in other clinical trials within 3 months before enrollment; 14\) Other subjects deemed unsuitable for inclusion by the researcher.