Application of Esketamine in Anesthesia of Autism Children
- Conditions
- Autism Spectrum Disorder
- Interventions
- Drug: propofol-sufentanil
- Registration Number
- NCT05960942
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. Autistic children have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The investigators intend to explore an optimum anesthetic regimen for autism children undergoing endoscopic procedures.
- Detailed Description
Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. The participants have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The primary objective was to compare the clinical efficacy and safety of propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and recovery in those children during/after either PE or PS sedation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- (1) aged 2-12 years;
- (2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- (3) evaluated as American Society of Anesthesiologists (ASA) physical status I-II;
- (4) scheduled for colonic TET procedure.
- (1) oral sedation (premedication) before intravenous catheter placement;
- (2) any contraindication to study medications;
- (3) other circumstances in which the investigator determined that a patient was not suitable for participation in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description propofol-sufentanil propofol-sufentanil - propofol-esketamine propofol combined with esketamine -
- Primary Outcome Measures
Name Time Method first movement time Up to 1 hour after the procedure the time from arriving Postanesthesia care unit to first gross limb movement after procedure
movement score during the procedure through study completion, an average of 10 minutes (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
- Secondary Outcome Measures
Name Time Method adverse event Up to 24 hour after the procedure (including hypoxia (SpO2 \<93% for \>10 seconds) or respiratory depression (apnea \>15 seconds), hypotension (mean arterial pressure \< 20% from baseline) or bradycardia (heart rate \< 60 /min and/or decrease in heart rate \> 20% from baseline) were recorded.
degree of emergence agitation Up to 2 hour after the procedure 1 = calm; 2 = not calm but could be easily calmed; 3 = not easily calmed, moderately agitated or restless; and 4 = combative, excited, or disoriented, trashing around
time to full recovery Up to 3 hour after the procedure achieve modified Aldrete score of 10 with the vital signs being normal and stable
arterial blood pressure through study completion, an average of 15 minutes arterial blood pressure was measured noninvasively
Trial Locations
- Locations (1)
Sir Run Run Hospital
🇨🇳Nanjing, China
Sir Run Run Hospital🇨🇳Nanjing, China