Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-6
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Children requiring special care or under the supervision of a court or social welfare agency;

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;

Trial design

Treatments tested in this trial

  • Propofol group
  • Remimazolam group

Treatment groups

96 Participants
are divided into 2 treatment groups