NCT06816173

Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

Effect of Propofol Versus Remimazolam Intravenous Anesthesia Combined With Regional or Caudal Block on Respiratory Depression in Young Children: A Randomized Controlled Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

Ninety-six children aged 3-6 years scheduled for surgery under general anesthesia were randomly divided into two groups. Initially, fentanyl was administered at a dose of 2-3 mcg/kg, and after 3 minutes, different test drugs were given according to the group assignment. In group P, propofol was administered intravenously at a dose of 2.0 mg/kg, while in group R, remimazolam was administered intravenously at a dose of 0.45-0.55 mg/kg. After achieving loss of consciousness (LoC, MOAA/S ≤ 1), a laryngeal mask was inserted, and spontaneous breathing was maintained. Subsequently, the test drugs were infused according to the group assignment, and both groups received a constant infusion of remifentanil at a rate of 0.05-0.4 μg/kg/min. After connecting the micro-infusion pump, regional or caudal block was performed. Once the local anesthetic had taken full effect, the infusion of remifentanil was stopped, and surgery began. The test drugs were stopped approximately 5 minutes before the end of the surgery, and the laryngeal mask was removed when spontaneous breathing reached a tidal volume of ≥ 6 ml/kg and a frequency of ≥ 15 breaths per minute. The following data were recorded: the time to loss of consciousness, the incidence of respiratory depression during anesthesia, the success rate of intravenous sedation, the incidence of postoperative agitation, recovery time, MOAA/S scores, and vital signs such as heart rate, blood pressure, and pulse oximetry.

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DRUG	Propofol group	Induction 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.
DRUG	Remimazolam group	Induction 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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-02-10
• Last updated: 2025-02-10

Locations

1 site across 1 country: China