Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

NCT ID: NCT06816173

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

group P（Propofol group）

Patients were assigned to group P (Propofol group) using a computer-generated random number table

Group Type: EXPERIMENTAL

Propofol group

Intervention Type: DRUG

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.

group R (Remimazolaml group)

Patients were assigned to group R (Remimazolaml group) using a computer-generated random number table

Group Type: EXPERIMENTAL

Remimazolam group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huacheng Liu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Yuhang Cai

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Locations

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Huacheng Liu

Role: CONTACT

huachengliu@163.com

18957755138

Yuhang Cai

Role: CONTACT

838097626@qq.com

18815091585

Other Identifiers

SAHoWMU-CR2025-03-102

Identifier Type: -

Identifier Source: org_study_id