Dose of Remimazolam in Children for Intubation

NCT06170918 | Unknown

• 1 other identifier: XJH-A-20231120
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.

Conditions

Anesthesia

Keywords

anesthesia induction; remimazolam; tracheal intubation; median effective dose

Outcome Measures

Primary Outcomes (2)

• half effective dose for intubation

  half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl

  from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes

• cardiovascular response to tracheal intubation

  cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation

  from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes

Secondary Outcomes (2)

• the time to loss of consciousness

  from injection of remimazolam to loss of consciousness, at an average of 3 minutes

• incidence of adverse events

  from injection of remimazolam to loss of consciousness, at an average of 3 minutes

Study Arms (1)

remimazolam

EXPERIMENTAL

Remimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg.

Drug: Remimazolam

Interventions

Remimazolam DRUG

remimazolam is given intravenously

Also known as: remimazolam besylate

remimazolam

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age from 3 to 12 years old
• patients scheduled for surgery under general anesthesia
• Body mass index in the range of 5% -95% of the same age group
• Consent was obtained from the patient and the family members, and an informed consent form was signed

You may not qualify if:

• American Society of Anesthesiologists status ≥3
• patients who cannot cooperate with intravenous anesthesia induction
• patients with risk of difficult airway
• patients who are allergic to benzodiazepines
• patients with neurological dysfunction
• Participate involved in other clinical investigators within 3 months

Sponsors & Collaborators

• Zhihong LU: lead

Related Publications (2)

• Fang YB, Wang CY, Gao YQ, Cai YH, Chen J, Zhang XL, Dong LQ, Shang-Guan WN, Liu HC. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial. Front Pharmacol. 2023 Feb 10;14:1090608. doi: 10.3389/fphar.2023.1090608. eCollection 2023.

  PMID: 36843931 BACKGROUND

• Kimoto Y, Hirano T, Kuratani N, Cavanaugh D, Mason KP. Remimazolam as an Adjunct to General Anesthesia in Children: Adverse Events and Outcomes in a Large Cohort of 418 Cases. J Clin Med. 2023 Jun 8;12(12):3930. doi: 10.3390/jcm12123930.

  PMID: 37373624 BACKGROUND

MeSH Terms

Interventions

remimazolam

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 14, 2023
• Study Start: December 20, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share