Esketamine and Propofol for Children With Autism Spectrum Disorder Undergoing Colonoscopy
- Conditions
- Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT05951465
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- Brief Summary
The purpose of this study is to examine the dose-response relationship of esketamine in combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.
- Detailed Description
Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. They 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 colonoscopic procedure in autism children. Propofol sedation for endoscopic procedures is safe and acceptable for children, especially those who express significant anxiety. Propofol-based sedation turned out to be the most effective dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain dose ketamine to propofol may increase the effectiveness without creating more adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- （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 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 eskatemine 0.3mg/kg + propofol Esketamine eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method. eskatemine 0.3mg/kg + propofol Propofol eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method. eskatemine 0.6mg/kg + propofol Esketamine eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method. eskatemine 0.6mg/kg + propofol Propofol eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
- Primary Outcome Measures
Name Time Method Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1 Procedure (This outcome is measured at the time of insertion of colonoscopy) The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2 Procedure (This outcome is measured at the time of insertion of colonoscopy) The objective is to determine the effective bolus dose in 95% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
- Secondary Outcome Measures
Name Time Method movement score during the procedure during the procudure (1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
adverse event during the procedure - 24 hours after procedure (including hypoxia (SpO2 \<93% for \>10 s) or respiratory depression (apnea \>15 s), hypotension (MAP \< 20% from baseline) or bradycardia (HR \< 60 x/min and/or decrease in HR \> 20% from baseline) were recorded.
arterial blood pressure during the procudure arterial blood pressure was measured noninvasively at four time points:T0: before induction of sedation,T1: immediately after induction of sedation, T2: complete evaluation of the coln through colonoscopy, T3: at the end of colonic TET procedure。
Trial Locations
- Locations (1)
Sir Run Run Hospital
🇨🇳Nanjing, Jiangsu, China