Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression

NCT06816173 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SAHoWMU-CR2025-03-102
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  During the induction and maintenance of anesthesia

Secondary Outcomes (5)

• Success rate of anesthesia induction and maintenance

  During the induction and maintenance of anesthesia

• Time to Loss of Consciousness (LoC)

  During anesthesia induction

• PAED scores of the subjects in the PACU

  Assess every 5 minutes after the child regains consciousness.

• Recovery time

  The moment of anesthesia recovery

• Time-frequency characteristics of electroencephalogram (EEG)

  Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)

Study Arms (2)

group P（Propofol group）

EXPERIMENTAL

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

Drug: Propofol group

group R (Remimazolaml group)

EXPERIMENTAL

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

Drug: Remimazolam group

Interventions

Propofol group 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 P（Propofol group）

Remimazolam group 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.

group R (Remimazolaml group)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yuhang Cai

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

18957755138; huachengliu@163.com

Yuhang Cai

CONTACT

18815091585; 838097626@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CN (1)