Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, propofol and remimazolam, to see how they affect breathing in young children who need anesthesia for surgery. Both medications are given through an intravenous (IV) line, but they work in different ways. Propofol is effective but can cause some discomfort when injected and may affect breathing and circulation. On the other hand, remimazolam is a newer medication that is easier to give, has less impact on breathing, and works quickly, making it potentially better for children. The goal of this study is to find out which of these two options is safer regarding respiratory depression, which means difficulty in breathing.

To participate in this trial, children must be between 3 and 6 years old and in good health, with a body mass index (BMI) within a specific range. Their parents or guardians need to agree to have them involved and sign a consent form. It's important to note that children with certain health issues, like severe allergies to medications or recent respiratory problems, would not be eligible for this study. If selected, participants will receive one of the two medications during their surgery, and the researchers will monitor their breathing closely. This study aims to help improve anesthesia safety for young children in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 3-6 years, gender unrestricted;
• • 2. American Society of Anesthesiologists (ASA) physical status classification of I-II;
• • 3. Body Mass Index (BMI) between 14 kg/m² and 25 kg/m²;
• • 4. Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;
• • 5. The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.
• Exclusion Criteria:
• • 1. Children requiring special care or under the supervision of a court or social welfare agency;
• • 2. Children who have received general anesthesia within 3 months prior to the screening period;
• • 3. Children with a history of respiratory diseases within the past 2 weeks or those deemed to have difficult airway management: Modified Mallampati score of III or IV;
• • 4. Children with severe cardiovascular diseases or endocrine system abnormalities;
• • 5. Children with known psychiatric disorders or cognitive impairments;
• • 6. Children with abnormal liver function, ALT (alanine aminotransferase) and/or AST (aspartate aminotransferase) \>1.5 times the upper limit of normal; children with total bilirubin exceeding the upper limit of normal; children with abnormal kidney function, creatinine and/or blood urea nitrogen higher than the upper limit of normal;
• • 7. Children known or suspected to be allergic to the study drug or benzodiazepines.