ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Tongji Hospital165 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Bidirectional Endoscopy

Interventions

RemimazolamDRUG

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

Eligibility

Sex: ALLMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 0-12 years old, 2. ASA I-II level; 3. Sign an informed consent form. Exclusion Criteria: 1. Developmental delay or neurological and psychiatric disorders; 2. Severe malnutrition or severe obesity; 3. High risk of stomach fullness and reflux aspiration; 4. Allergic to benzodiazepines and opioids; 5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours; 6. Severe sleep apnea; 7. Abnormal liver and kidney function; 8. Recently participated in other clinical studies.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Respiratory Suppression Incidence

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

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

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

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.

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

Time Records

induction time

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

Data from ClinicalTrials.gov

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