## Protocol Section
### Identification Module
**NCT ID:** NCT06419543

**Brief Title:** Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

**Official Title:** Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: a Prospective Observation Study

#### Organization Study ID Info
**ID:** PRPG
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tongji Hospital

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** aijun xu

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Endoscopy, Gastrointestinal

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The first induction dose of remimazolam is 0.1mg/kg.

**Intervention Names:**

- Drug: Remimazolam

**Label:** 0.1mg/kg of remimazolam

#### Arm Group 2

**Description:** The first induction dose of remimazolam is 0.2mg/kg.

**Intervention Names:**

- Drug: Remimazolam

**Label:** 0.2mg/kg of remimazolam

#### Arm Group 3

**Description:** The first induction dose of remimazolam is 0.3mg/kg.

**Intervention Names:**

- Drug: Remimazolam

**Label:** 0.3mg/kg of remimazolam

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 0.1mg/kg of remimazolam

- 0.2mg/kg of remimazolam

- 0.3mg/kg of remimazolam

**Description:** Observe the incidence of paradoxical reactions after the first induction.

**Name:** Remimazolam

**Other Names:**

- remimazolam besylate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** observe the incidence of paradoxical reaction within 2 minutes

**Measure:** incidence of paradoxical reaction

**Time Frame:** 2 minutes after first infusion of remimazolam

#### Secondary Outcomes

**Description:** observe the performance and duration of paradoxical reaction within 2 minutes

**Measure:** performance and duration of paradoxical reaction

**Time Frame:** 2 minutes after first infusion of remimazolam

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

**Measure:** dosage of sedative drugs

**Time Frame:** First infusion until end of remimazolam administration

**Description:** anesthesia time, induction time, surgical time, awakening time, and recovery time

**Measure:** time records

**Time Frame:** 1 day

**Description:** 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.

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

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 1-18 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.

**Maximum Age:** 18 Years

**Minimum Age:** 1 Year

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** We select children who choose to have a painless gastrointestinal endoscopy at Tongji Hospital.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** changmujun@hotmail.com

**Name:** mujun Chang, doctor

**Phone:** +862783663625

**Role:** CONTACT

**Contact 2:**

**Email:** tongjihlunli@163.com

**Name:** aihua Du, doctor

**Phone:** +862783663625

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospita

**Name:** aihua Du, doctor

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
