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Completed

NCT Number: NCT06121609

ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

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Key information

Conditions

Bidirectional Endoscopy

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 0-12 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 24 hours;
  • Severe sleep apnea;
  • Abnormal liver and kidney function;
  • Recently participated in other clinical studies.

Treatment and study plan

Remimazolam

Drug

Exploring ED90 induced by remimazolam anesthesia in children of different age groups undergoing painless bidirectional endoscopy

Other names: Remimazolam besylate

Primary outcomes

  1. Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S

    Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

    Using the modified MOAA/S scoring table（ranging from 5-0） to evaluate if the sedation is successful.

    5 points：Respond quickly to names spoken in a normal tone 4 points：Showing a drowsy reaction to names spoken in a normal tone 3 points：Only react after loudly and/or repeatedly calling the name 2 points：Response immediately after slight stimulation or shaking

    1point：Response only occurs after compression of the trapezius muscle that causes pain 0 point：No response after compression of the trapezius muscle

Secondary outcomes

  1. Respiratory Suppression Incidence

    Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

    Respiratory frequency<8 times/min or SP02<90%

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

    Time frame: From the start of drug administration for induction to 24h after the operation.

    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.

  3. Time Records

    Time frame: The entire duration of anesthesia：From the start of drug administration for induction until the patient's awakening.

    induction time

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children: a Biased Coin up and Down Sequential Trial

Acronym: ED90

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Dec 2, 2025

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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