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Completed

NCT Number: NCT05686863

Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

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.

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Key information

Conditions

Drug Effect

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Remimazolam

Drug

Remazolam for sedation in children undergoing bidirectional endoscopy

Other names: Rema

Esketamine

Drug

Esketamine

Other names: Esket

Propofol

Drug

Propofol

Other names: Prop

Remifentanil

Drug

remifentanil

Other names: remifen

Primary outcomes

  1. Sedation success rate

    Time frame: Procedure (From the beginning of anesthesia to the end of examination)

    Improved observer alertness and sedation score, MOAA/S

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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