To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
Known allergy to any component of the study drug or history of allergic constitution;
History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
ASA physical status classification IV;
Parallel
Esketamine
DrugContinuous intraoperative infusion of esketamine at 0.3 mg/kg/h
normal Saline
DrugPatients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10:Extremely severe itching.
The incidence of sleep disorders on postoperative days 1-3
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first, second and third day after surgery. The AIS has a total of 8 items, with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia. The investigators asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AIS scores as statistical indicators.
Postoperative anxiety
Patients completed the anxiety rating scales (HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in anxiety. The investigators recorded HADS-A scores as statistical indicators
Postoperative depression
Patients completed the depression rating scales (HADS-D, Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in depression. The investigators recorded HADS-D scores as statistical indicators.
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