- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268872
Dynamic Effects of Different Anesthetic Agents on the Immune Function of Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhengzhou
-
Henan, Zhengzhou, China, 450000
- Henan Provincial People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propofol group
Anesthesia induction: 1.5-2.5 mg/kg IV bolus; Anesthesia maintenance: 4-12 mg/kg/h infusion
|
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.
|
|
Active Comparator: Sevoflurane group
Anesthesia induction: 6% concentration inhaled for 2 minutes; Anesthesia maintenance: 0.5-3% concentration
|
Induction with 8% concentration inhaled for approximately 2 minutes, maintenance concentration 0.5-3%.
|
|
Active Comparator: Ciprofol group
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
|
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.
|
|
Placebo Comparator: Control group
subjects will not undergo anesthesia but will remain in a supine position on a hospital trolley for 3 hours.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HenanPPH-LFF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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