Dynamic Effects of Different Anesthetic Agents on the Immune Function of Healthy Volunteers

Обзор

This study recruits healthy volunteers and randomly assigns them in a 1:1:1:1 ratio to the following groups: Propofol group, Sevoflurane group, Ciprofol group, and Control group. Subjects in the different groups will undergo anesthesia with the corresponding general anesthetic drug, while subjects in the Control group will receive no anesthesia. Peripheral blood samples will be collected at specified time points: before anesthesia induction, upon emergence from anesthesia, 24 hours after anesthesia, and 48 hours after anesthesia. Single-cell multi-omics analysis will be performed on these samples using single-cell sequencing technology. The aim is to investigate the independent effects of different general anesthetic drugs on human immune function in the absence of surgical trauma, and to further explore the potential immunomodulatory effects of commonly used clinical anesthetics.

Вмешательства

• Препарат Propofol group
  Induction with 1.5-2.5 mg/kg IV bolus until loss of consciousness (loss of eyelash reflex), maintenance with 4-12 mg/kg/h target-controlled infusion.
• Препарат Sevoflurane group
  Induction with 8% concentration inhaled for approximately 2 minutes, maintenance concentration 0.5-3%.
• Препарат Ciprofol group
  Induction with 0.4 mg/kg IV bolus over 10-30s; if anesthesia depth is insufficient, additional doses not exceeding 0.2 mg/kg may be given; maintenance with 0.4-2.4 mg/kg/h target-controlled infusion.
• Другое Control group
  subjects will not receive anesthesia but will remain in a supine position on a hospital trolley for 3 hours, after which they will be sent to the Post-Anesthesia Care Unit (PACU).

Первичные конечные точки

• Single-cell multi-omics data obtained from peripheral blood mononuclear cells; metabolome, lipidome, and proteome data obtained from plasma through detection; whole genome sequencing data. [Срок оценки: Peripheral blood samples will be collected at specified time points: before anesthesia induction, upon emergence from anesthesia, 24 hours after anesthesia, and 48 hours after anesthesia. Single-cell multi-omics analysis will be performed on these sample]

Критерии участия

Критерии включения

Volunteers undergo routine blood tests, liver function, kidney function, coagulation function, and routine 12-lead electrocardiogram examination before the trial. Any item showing no significant abnormalities; Age 20-30 years; ASA physical status I; BMI (Body Mass Index) 18-28 kg/m².

Критерии исключения

History of neurological/psychiatric diseases, immune system diseases, or any type of chronic disease; History of surgical anesthesia; History of bad habits such as drug abuse, smoking or excessive drinking; Women during menstruation, pregnancy, or lactation; Recent use of immunosuppressants, hormones, non-steroidal anti-inflammatory drugs; Intake of antibiotics, probiotics, prebiotics, or other supplements within three months prior to stool sample collection; Recent history of diarrhea, inflammatory bowel disease, or other diseases severely affecting gut microbiota structure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Китай · 1 центр

• Henan Provincial People's Hospital — Henan

Идентификаторы

NCT: NCT07268872 · HenanPPH-LFF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗