Endoscopy, GastrointestinalNCT06419543
Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy
A study testing Remimazolam in people with Endoscopy, Gastrointestinal, run by Tongji Hospital at 1 site in China.
Trial summary
Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Endoscopy, Gastrointestinal
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-12 years old
- ASA I-II level
- Sign an informed consent form
Who cannot join
- 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 24hours
- Severe sleep apnea
- Abnormal liver and kidney function
- Recently participated in other clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial
Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.
Read the 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
- Endoscopy, Gastrointestinal
- Being tested
- Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called remimazolam besylate
Observe the incidence of paradoxical reactions after the first induction.
| Study group | Role | What they receive |
|---|---|---|
| Group R1 | Experimental | The first induction dose of remimazolam is 0.1mg/kg. Receives: Drug: Remimazolam |
| Group R2 | Experimental | The first induction dose of remimazolam is 0.2mg/kg. Receives: Drug: Remimazolam |
| Group R3 | Experimental | The first induction dose of remimazolam is 0.3mg/kg. Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of paradoxical reaction
observe the incidence of paradoxical reaction within 2 minutes
Measured: 2 minutes after first infusion of remimazolam
Secondary outcomes (4)
performance and duration of paradoxical reaction
observe the performance and duration of paradoxical reaction within 2 minutes
Measured: 2 minutes after first infusion of remimazolam
dosage of sedative drugs
Total dose of the first administered plus supplemental doses of sedative drugs.
Measured: First infusion until end of remimazolam administration
time records
anesthesia time, induction time, surgical time, awakening time, and recovery time
Measured: 1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start20 May 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy, GastrointestinalStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419543
- Sponsor's protocol ID
- PRPG
- Status last verified
- Oct 2024
- First submitted
- 13 May 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: Incidence, Characters and Its Impact on Prognostic Outcomes-- a Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06419543
- Acronym / sponsor ID
- PRPG
- Conditions
- Endoscopy, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R1 | Experimental | Drug: RemimazolamThe first induction dose of remimazolam is 0.1mg/kg. |
| Group R2 | Experimental | Drug: RemimazolamThe first induction dose of remimazolam is 0.2mg/kg. |
| Group R3 | Experimental | Drug: RemimazolamThe first induction dose of remimazolam is 0.3mg/kg. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-12 years old
- ASA I-II level
- Sign an informed consent form
Key exclusion criteria (8 listed)
- 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 24hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAlso: remimazolam besylateObserve the incidence of paradoxical reactions after the first induction. | Drug | Group R1, Group R2, Group R3 |
Primary outcome
incidence of paradoxical reaction
Time frame: 2 minutes after first infusion of remimazolam
observe the incidence of paradoxical reaction within 2 minutes
4 secondary outcomes
performance and duration of paradoxical reaction
Time frame: 2 minutes after first infusion of remimazolam
dosage of sedative drugs
Time frame: First infusion until end of remimazolam administration
time records
Time frame: 1 day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aihua Du, Dr. study chair
Tongji Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam in people with Endoscopy, Gastrointestinal, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of paradoxical reaction (time frame: 2 minutes after first infusion of remimazolam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.