Dose of Remimazolam in Children for Intubation

Anesthesia Clinical Trial

— DRIP  

Official title:

Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06170918
• Other study ID #: XJH-A-20231120
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Remimazolam
remimazolam is given intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	the time to loss of consciousness		from injection of remimazolam to loss of consciousness, at an average of 3 minutes
Secondary	incidence of adverse events	adverse events include bradycardia, hypotension, hypoxemia, and injection pain	from injection of remimazolam to loss of consciousness, at an average of 3 minutes