Drug EffectNCT05686863
Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children
A study testing Remimazolam, Esketamine and Propofol in people with Drug Effect, run by Tongji Hospital at 1 site in China.
Trial summary
To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- Remimazolam, Esketamine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2023to 7 Jul 2023
- 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 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-17;
- ASA Class I-II;
- Sign the informed consent form.
Who cannot join
- Patients with high risk of stomach satiety and reflux aspiration;
- Patients allergic to the study drug;
- Obesity or severe malnutrition;
- Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
- Hypertension without treatment;
- Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range);
- Other congenital diseases or acute and chronic diseases that affect the observation of curative effect;
- Participate in other clinical studies within 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children
To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
Read the detailed description
It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
- Conditions
- Drug Effect
- Being tested
- Remimazolam, Esketamine, Propofol, remifentanil
- Keywords
- remiazolam, esketamine, bidirectional endoscopy, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Rema
Remazolam for sedation in children undergoing bidirectional endoscopy
EsketamineDrug
Also called Esket
Esketamine
PropofolDrug
Also called Prop
Propofol
remifentanilDrug
Also called remifen
remifentanil
| Study group | Role | What they receive |
|---|---|---|
| P group | Active comparator | induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping Receives: Drug: Esketamine; Drug: Propofol; Drug: remifentanil |
| R group | Experimental | induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping Receives: Drug: Remimazolam; Drug: Esketamine; Drug: remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation success rate
Improved observer alertness and sedation score, MOAA/S
Measured: Procedure (From the beginning of anesthesia to the end of examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start18 Jan 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug EffectStudies 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
- Model description
- Prospective, randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Hong Liu, Dr, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686863
- Sponsor's protocol ID
- RECES
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data can be requested from the main researchers via email
Publications
Chu T, Zhou S, Wan Y, Liu Q, Xin Y, Tian Z, Yan T, Xu A. Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial. Front Pharmacol. 2024 Feb 5;15:1298409. doi: 10.3389/fphar.2024.1298409. eCollection 2024.
PubMed 38375038
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children
- ClinicalTrials.gov ID
- NCT05686863
- Acronym / sponsor ID
- RECES
- Conditions
- Drug Effect
- Keywords
- remiazolam, esketamine, bidirectional endoscopy, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 17 Jan 2023 (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.
To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
Detailed description
It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| P group | Active comparator | Drug: Esketamine, Drug: Propofol, Drug: remifentanilinduction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping |
| R group | Experimental | Drug: Remimazolam, Drug: Esketamine, Drug: remifentanilinduction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0-17;
- ASA Class I-II;
- Sign the informed consent form.
Key exclusion criteria (8 listed)
- Patients with high risk of stomach satiety and reflux aspiration;
- Patients allergic to the study drug;
- Obesity or severe malnutrition;
- Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
- Hypertension without treatment;
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: RemaRemazolam for sedation in children undergoing bidirectional endoscopy | Drug | R group |
| EsketamineAlso: EsketEsketamine | Drug | P group, R group |
| PropofolAlso: PropPropofol | Drug | P group |
| remifentanilAlso: remifenremifentanil | Drug | P group, R group |
Primary outcome
Sedation success rate
Time frame: Procedure (From the beginning of anesthesia to the end of examination)
Improved observer alertness and sedation score, MOAA/S
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 21 Aug 2023.
- Derived from this study: PubMed 38375038Chu T, Zhou S, Wan Y, Liu Q, Xin Y, Tian Z, Yan T, Xu A. Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial. Front Pharmacol. 2024 Feb 5;15:1298409. doi: 10.3389/fphar.2024.1298409. eCollection 2024.
- Individual participant dataSharing planned: No. Research data can be requested from the main researchers via email
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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.
Hong Liu, Dr study director
Tongji Hospital
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, Esketamine and Propofol in people with Drug Effect, 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 21 Aug 2023. 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?
Sedation success rate (time frame: Procedure (From the beginning of anesthesia to the end of examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686863, which also lists 1 linked publication.
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 21 Aug 2023.