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.
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;
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;
Parallel
Propofol group
DrugInduction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer propofol intravenously at a dose of 2.0 mg/kg. Maintenance phase: Infuse propofol (4-12 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.
Remimazolam group
DrugInduction phase: Administer fentanyl at a dose of 2-3 mcg/kg, and after 3 minutes, administer remimazolam intravenously at a dose of 0.45-0.55 mg/kg. Maintenance phase: Infuse remimazolam (1-3 mg/kg/h) and maintain a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. Subsequently, perform regional block (0.25% ropivacaine 0.5 ml/kg) or caudal block (lower limbs or perineal area: 0.25% ropivacaine 0.5 ml/kg; lower abdomen/inguinal area: 0.25% ropivacaine 0.75 ml/kg). After the local anesthetic has taken full effect, stop the infusion of remifentanil.
Incidence of respiratory depression during anesthesia
During the induction and maintenance of anesthesia, the occurrence of respiratory depression is defined by meeting at least one of the following criteria: 1. Spontaneous respiratory rate (RR) less than 12 breaths/min for a duration of 1 minute, or peripheral oxygen saturation (SpO2) less than 92% for a duration of 10 seconds. 2. Loss of spontaneous breathing.
Success rate of anesthesia induction and maintenance
Successful anesthesia induction is defined as achieving loss of consciousness (LoC) without the use of rescue sedation during the induction period. Successful anesthesia maintenance is defined as not requiring rescue sedation or interruption of the study drug during the maintenance period.
Time to Loss of Consciousness (LoC)
The time from the start of administration of the study drug to the loss of consciousness in the subjects, defined as MOAA/S ≤ 1.
PAED scores of the subjects in the PACU
The PAED scale consists of 5 items, which are: obeying commands and being communicative, purposeful behavior, attention to the surrounding environment, restlessness, and crying that cannot be comforted. A PAED score of ≥12 is defined as delirium.
Recovery time
The time from the cessation of the study drug infusion during anesthesia maintenance to the recovery of the subject (defined as the first time when the MOAA/S score is continuously three times 5).
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