NCT05686863

Brief Summary

To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

January 7, 2023

Last Update Submit

August 16, 2023

Conditions

Drug Effect

Keywords

remiazolamesketaminebidirectional endoscopychildren

Outcome Measures

Primary Outcomes (1)

  • Sedation success rate

    Improved observer alertness and sedation score, MOAA/S

    Procedure (From the beginning of anesthesia to the end of examination)

Study Arms (2)

P group

ACTIVE COMPARATOR

induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping

Drug: EsketamineDrug: PropofolDrug: remifentanil

R group

EXPERIMENTAL

induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping

Drug: RemimazolamDrug: EsketamineDrug: remifentanil

Interventions

RemimazolamDRUG

Remazolam for sedation in children undergoing bidirectional endoscopy

Also known as: Rema
R group
EsketamineDRUG

Esketamine

Also known as: Esket
P groupR group
PropofolDRUG

Propofol

Also known as: Prop
P group
remifentanilDRUG

remifentanil

Also known as: remifen
P groupR group

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 0-17;
  • ASA Class I-II;
  • Sign the informed consent form.

You may not qualify if:

  • Patients with high risk of stomach satiety and reflux aspiration;
  • Patients allergic to the study drug;
  • Obesity or severe malnutrition;
  • Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
  • Hypertension without treatment;
  • Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
  • Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
  • Participate in other clinical studies within 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

  • Chu T, Zhou S, Wan Y, Liu Q, Xin Y, Tian Z, Yan T, Xu A. Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial. Front Pharmacol. 2024 Feb 5;15:1298409. doi: 10.3389/fphar.2024.1298409. eCollection 2024.

    PMID: 38375038DERIVED

MeSH Terms

Interventions

remimazolamEsketaminePropofolRemifentanil

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hong Liu, Dr

    Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Since propofol is white uniform emulsion, and ramazolam is colorless, clear and transparent liquid, anesthesiologists and surgeons may see the color of the study drug during operation, so this study is a single blind clinical study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. aijun Xu

Study Record Dates

First Submitted

January 7, 2023

First Posted

January 17, 2023

Study Start

January 18, 2023

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Research data can be requested from the main researchers via email

Locations

CN(1)