Dose of Remimazolam in Children for Intubation

Not Applicable

Not yet recruiting

• Conditions: Anesthesia
• Interventions: Drug: Remimazolam

• Registration Number: NCT06170918
• Lead Sponsor: Zhihong LU

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Study Start: 2023-12-20
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
half effective dose for intubation	from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes	half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl
cardiovascular response to tracheal intubation	from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes	cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation

Secondary Outcome Measures

Name	Time	Method
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	adverse events include bradycardia, hypotension, hypoxemia, and injection pain