Effect of Esketamine on 95% Induction Dose of Remimazolam

Second Affiliated Hospital of Wenzhou Medical University80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pediatric Gastroscopy

Interventions

Remimazolam besylate and low-dose EsketamineDRUG

Esketamine was injected intravenously 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg

Remimazolam besylate and Medium dose EsketamineDRUG

Esketamine was injected intravenously 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sedation induction time

the patients' unresponsiveness to the mild shaking of their shoulder

Time frame: during anaesthetic induction

Secondary Outcomes

Modified observer's assessment of alertness#sedation#MOAA/S#scale

5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation

Time frame: 1 minutes after single intravenous bolus remimazolam

Recovery times

The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9

Time frame: Within up to 30 minutes after operation

VAS(The difficulty of gastroscope insertion)

VAS values range from 0 to 10. A value of 0 represents that gastroscopy placement is very easy.and 10 represents that gastroscopy placement is very difficult.

Time frame: Moment of endoscopic insertion

Number of children with adverse effects

Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation \<90% Any adverse effects requiring interventions

Time frame: Within 24 hours after completion of gastroscopy.