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

NCT07268872 | Enrolling By Invitation

• 1 other identifier: HenanPPH-LFF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (4)

Propofol group

ACTIVE COMPARATOR

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

Drug: Propofol group

Sevoflurane group

ACTIVE COMPARATOR

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

Drug: Sevoflurane group

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

Drug: Ciprofol group

Control group

PLACEBO COMPARATOR

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

Other: Control group

Interventions

Propofol group DRUG

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.

Propofol group

Sevoflurane group DRUG

Induction with 8% concentration inhaled for approximately 2 minutes, maintenance concentration 0.5-3%.

Sevoflurane group

Ciprofol group DRUG

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.

Ciprofol group

Control group OTHER

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).

Control group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Henan, Zhengzhou, 450000, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)