Clinical trial NCT06303037: Effect of Esketamine on 95% Induction Dose of Remimazolam
Official title: Determination of the 95% Effective Dose of Remimazolam in Combination With Different Doses of Esketamine During Gastroscopy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric
Gastroscopy
ED95
Sedation
Keywords: remimazolam
esketamine
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

Detailed description: Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.

Eligibility criteria: Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II#;
2. aged 3#12 years#;
3. children with weight for age within the normal range#;
4. were scheduled to have a gastroscopy;

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine;
3. recently respiratory infection, mental disorder;
4. other reasons that researchers hold it is not appropriate to participate in this trial.

Primary outcomes:
measure: Sedation induction time
timeFrame: during anaesthetic induction
Secondary outcomes:
measure: Modified observer's assessment of alertness#sedation#MOAA/S#scale
timeFrame: 1 minutes after single intravenous bolus remimazolam
measure: Recovery times
timeFrame: Within up to 30 minutes after operation
measure: VAS(The difficulty of gastroscope insertion)
timeFrame: Moment of endoscopic insertion
measure: Number of children with adverse effects
timeFrame: Within 24 hours after completion of gastroscopy.
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Huacheng Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Yuhang Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Qiaoqiao Wang
role: PRINCIPAL_INVESTIGATOR
References: