Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression (NCT06816173) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression
China96 participantsStarted 2025-02
Plain-language summary
General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 3-6 years, gender unrestricted;
. American Society of Anesthesiologists (ASA) physical status classification of I-II;
. Body Mass Index (BMI) between 14 kg/m² and 25 kg/m²;
. Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;
. The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.
Exclusion criteria
. Children requiring special care or under the supervision of a court or social welfare agency;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of respiratory depression during anesthesia
Timeframe: During the induction and maintenance of anesthesia
Trial details
NCT IDNCT06816173
SponsorSecond Affiliated Hospital of Wenzhou Medical University
. Children who have received general anesthesia within 3 months prior to the screening period;
. 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;
. Children with severe cardiovascular diseases or endocrine system abnormalities;
. Children with known psychiatric disorders or cognitive impairments;
. 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;
. Children known or suspected to be allergic to the study drug or benzodiazepines.