NCT05951465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

October 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 25, 2023

Last Update Submit

October 7, 2023

Conditions

Autism Spectrum Disorder

Keywords

colonoscopyanaesthesiaautism spectrum disorderpropofolesketamine

Outcome Measures

Primary Outcomes (2)

  • Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1

    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.

    Procedure (This outcome is measured at the time of insertion of colonoscopy)

  • Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2

    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.

    Procedure (This outcome is measured at the time of insertion of colonoscopy)

Secondary Outcomes (3)

  • movement score during the procedure

    during the procudure

  • arterial blood pressure

    during the procudure

  • adverse event

    during the procedure - 24 hours after procedure

Study Arms (2)

eskatemine 0.3mg/kg + propofol

EXPERIMENTAL

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.

Drug: EsketamineDrug: Propofol

eskatemine 0.6mg/kg + propofol

EXPERIMENTAL

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.

Drug: EsketamineDrug: Propofol

Interventions

EsketamineDRUG

esketamine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5 mg/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
PropofolDRUG

propofol

eskatemine 0.3mg/kg + propofoleskatemine 0.6mg/kg + propofol

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • （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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

EsketaminePropofol

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

July 19, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

October 10, 2023

Record last verified: 2023-05

Locations

CN(1)