Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder

NCT06633315 | Completed Phase 2

• 1 other identifier: MCHH_05
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, Methods:aged 2-6 years,, ASA grade I or II. The children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (DEXL group,n=100）The high-dose group of dexmedetomidine (DEXH group,n=100) and the group of esketamine combined with dexmedetomidine (DEXE group,n=100). The DEXL group received 2.5 μ g/kg of dexmedetomidine nasal drops, the DEXH group received 3 μ g/kg of dexmedetomidine nasal drops, and the DEXE group received 2 μ g/kg of dexmedetomidine nasal drops plus 0.5 mg/kg of ketamine nasal drops. Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3).

Conditions

Autism Spectrum Disorder; Dexmedetomidine; Esketamine; Sedation

Outcome Measures

Primary Outcomes (1)

• The first success rate of nasal drip

  After the first dose of nasal drip administration, the examination was successfully completed and effective diagnostic images and reports were obtained.

  during the procedure

Study Arms (3)

High dose dexmedetomidine

EXPERIMENTAL

received high dose dexmedetomidine,received dexmedetomidine 3 μ g/kg nasal drops,Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients.

Other: high dos dexmedetomidine

Dexmedetomidine and esketamine

EXPERIMENTAL

received dexmedetomidine plus esketamine ,received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops.Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients.

Other: dexmedetomidine and esketamine

Low dos dexmedetomidine

EXPERIMENTAL

received dexmedetomidine 2.5 μ g/kg nasal drops, Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3). Compare the incidence of adverse reactions during sedation, including bradycardia, nausea and vomiting, nystagmus, postoperative agitation, and delayed awakening, among the three groups of patients.

Other: low dos dexmedetomidine

Interventions

low dos dexmedetomidine OTHER

received dexmedetomidine 2.5 μ g/kg nasal drops

Low dos dexmedetomidine

high dos dexmedetomidine OTHER

received dexmedetomidine 3 μ g/kg nasal drops

High dose dexmedetomidine

dexmedetomidine and esketamine OTHER

received dexmedetomidine 2 μ g/kg nasal drops plus ketamine 0.5 mg/kg nasal drops

Dexmedetomidine and esketamine

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of autism spectrum disorder Aged 2-6 years, ASA grade I or II

You may not qualify if:

• Upper respiratory tract infections, Severe respiratory system related diseases Congenital heart disease Liver and kidney dysfunction. Contraindications for ketamine and dexmedetomidine, Expected difficult airways. Anesthetic or sedative drugs used in the last week.

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province,

Wuhan, Hubei, 43000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Dexmedetomidine; Esketamine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Linli Yue, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: The children were randomly divided into three groups using a random number table method: The low-dose dexmedetomidine group ( DL group,n = 30) ， Group DL received dexmedetomidine 2.5 μ g/kg nasal drops, The high-dose group of dexmedetomidine (DH group),received dexmedetomidine 3 μ g/kg nasal drops The combination group (DE group, n=30). received dexmedetomidine 2 μ g/kg nasal drops plus esketamine 0.5 mg/kg nasal drops. Record the Modified Vigilance/Sedation (MOAA/S) Scale score, Mask Acceptance Scale (MAS) score, one-time medication success rate, and number of salvage medication cases 30 minutes after nasal drip. Record the vital signs of four groups of patients during the examination process, including their basic

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-09

Locations

CN (1)