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Completed

NCT Number: NCT06419543

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

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Key information

Conditions

Endoscopy, Gastrointestinal

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

About this study

Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 1-12 years old
  • ASA I-II level
  • Sign an informed consent form

Exclusion criteria

  • Developmental delay or neurological and psychiatric disorders
  • Severe malnutrition or severe obesity
  • High risk of stomach fullness and reflux aspiration
  • Allergic to benzodiazepines and opioids
  • Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
  • Severe sleep apnea
  • Abnormal liver and kidney function
  • Recently participated in other clinical studies

Treatment and study plan

Remimazolam

Drug

Observe the incidence of paradoxical reactions after the first induction.

Other names: remimazolam besylate

Primary outcomes

  1. incidence of paradoxical reaction

    Time frame: 2 minutes after first infusion of remimazolam

    observe the incidence of paradoxical reaction within 2 minutes

Secondary outcomes

  1. performance and duration of paradoxical reaction

    Time frame: 2 minutes after first infusion of remimazolam

    observe the performance and duration of paradoxical reaction within 2 minutes

  2. dosage of sedative drugs

    Time frame: First infusion until end of remimazolam administration

    Total dose of the first administered plus supplemental doses of sedative drugs.

  3. time records

    Time frame: 1 day

    anesthesia time, induction time, surgical time, awakening time, and recovery time

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 1 day

    respiratory suppression incidence;intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 17, 2024
Registry last updated
Oct 30, 2024

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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