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A Prospective Randomized Controlled Trial Comparing Dexmedetomidine and Midazolam on Immune Modulation and Clinical Efficacy in Children with Septic Shock

A Prospective Randomized Controlled Trial Comparing Dexmedetomidine and Midazolam on Immune Modulation and Clinical Efficacy in Children with Septic Shock

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105614
Enrollment
Unknown
Registered
2025-07-08
Start date
2024-01-12
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

Group A: Midazolam group:The first dose was 0.1~0.3 mg/kg intravenous pumping (10-15 min), and the maintenance dose was 1-5 µg/kg/min intravenous pumping
Group B: Dexmedetomidine group:The first dose was 0.5~1.0 µg/kg intravenous pumping (10-15 min), and the maintenance dose was 0.3-0.6 µg/kg/h intravenous pumping

Sponsors

Women and Children's Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Collected from January 2024 to December 2024 who were admitted to the PICU of our hospital and diagnosed with septic shock, aged 28 days ~ 18 years old, and gender is not limited. 2. There is a "period of instability" of organ function that requires moderate to severe sedation strategies (such as severe human-machine confrontation, acute respiratory distress syndrome in children, severe head injury and increased intracranial pressure, status epilepticus, before the use of neuromuscular blocking agents, etc.). 3. The diagnostic criteria for septic shock refer to the International Consensus Conference on Sepsis in Children: Definition of Sepsis and Organ Dysfunction in Children (2005 edition). 4. Moderate to severe sedation in the bispectral index (BIS). During the sedation period, all children met the RASS score of -3~-4, and the BIS index was 40~80.

Exclusion criteria

Exclusion criteria: 1. Tumors and neoplasia lesions; 2. Autoimmune diseases; 3. Inborn metabolic diseases; 4. Genetic and chromosomal lesions; 5. Tuberculosis; 6. Parasitic diseases; 7. Liver and kidney failure; 8. Children with immunosuppressive drugs and adverse drug reactions.

Design outcomes

Primary

MeasureTime frame
Immune cytokine levels;Lymphocyte subsets;

Secondary

MeasureTime frame
28-day mortality;Hemodynamic parameters;

Countries

China

Contacts

Public ContactYao Zheng

Women and Children's Hospital of Ningbo University

zhengyao125@163.com+86 574 8798 2426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026