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Clinical Trials/NCT07268872
NCT07268872
Enrolling By Invitation
Not Applicable

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

Henan Provincial People's Hospital1 site in 1 country80 target enrollmentStarted: November 21, 2025Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
80
Locations
1
Primary Endpoint
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.

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Propofol group

Active Comparator

Anesthesia induction: 1.5-2.5 mg/kg IV bolus; Anesthesia maintenance: 4-12 mg/kg/h infusion

Intervention: Propofol group (Drug)

Sevoflurane group

Active Comparator

Anesthesia induction: 6% concentration inhaled for 2 minutes; Anesthesia maintenance: 0.5-3% concentration

Intervention: Sevoflurane group (Drug)

Ciprofol group

Active Comparator

Anesthesia induction: 0.4 mg/kg IV injection over 10-30s; if anesthesia depth is insufficient, additional doses not exceeding 0.2 mg/kg may be given; Anesthesia maintenance: 0.4-2.4 mg/kg/h infusion

Intervention: Ciprofol group (Drug)

Control group

Placebo Comparator

subjects will not undergo anesthesia but will remain in a supine position on a hospital trolley for 3 hours.

Intervention: Control group (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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