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

Overview

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.

Interventions

• Drug 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.
• Drug Sevoflurane group
  Induction with 8% concentration inhaled for approximately 2 minutes, maintenance concentration 0.5-3%.
• Drug 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.
• Other 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).

Primary outcome measures

• 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. [Time frame: 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]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

China · 1 center

• Henan Provincial People's Hospital — Henan

Identifiers

NCT: NCT07268872 · HenanPPH-LFF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗