Endoscopic HemostasisPhase 4NCT05554965
Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding
A Phase 4 study testing Propofol and Remimazolam besylate in people with Endoscopic Hemostasis and Sedation, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Hemostasis, Sedation
- What is being tested?
- Propofol and Remimazolam besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 30 Dec 2022
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with bleeding from ruptured esophageal and gastric varices
- Endoscopic hemostatic treatment was performed
- Body Mass Index(BMI)18～28kg/m2
Who cannot join
- History or evidence of increased risk of sedation/anesthesia;
- Pregnant and lactating women;
- Have participated in other drug trials within 30 days prior to enrollment;
- those with contraindications to propofol, opioids and their remedies;
- Unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Lu Wang, 15927142942, 410669243@qq.com
About this study
Official title: Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
Read the detailed description
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
- Conditions
- Endoscopic Hemostasis, Sedation
- Being tested
- Propofol, Remimazolam besylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Active Comparator
Remifentanil maintenance analgesic dose was 1.2-9 μg/kg/h. If the CPOT score ≥3 at the time of maintenance administration, dose adjustment can be considered. Propofol was used for sedation at a loading dose of 0.5mg/kg and a maintenance dose of 1.5mg/kg/h.
Remimazolam besylateDrug
Also called Experimental
Remifentanil was administered at a maintenance dose of 1.2-9 μg/kg/h for analgesia. If CPOT score ≥3 during maintenance administration, dose adjustment could be considered. For sedation, remazolam besylate was given a load of 0.1-0.2mg/kg and a maintenance dose of 0.1-0.3mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | The control group was sedated with propofol Receives: Drug: Propofol |
| Remimazolam besylate | Experimental | The experimental group was given remazolam besylate for sedation Receives: Drug: Remimazolam besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation scores
sedation scores were performed during administration,Richmond Agitation-Sedation Scale（RASS）1~-2 was defined as compliance,Otherwise, sedation was considered inadequate
Measured: From the begin to 48 hours after procedure
Secondary outcomes (2)
Rate of adverse events
Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc
Measured: Within 2 hours from the start of administration to the end of administration
Vital signs
Systolic and Diastolic Blood Pressure
Measured: From the begin to 48 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start10 Feb 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic HemostasisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554965
- Sponsor's protocol ID
- 20220819
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared with team members
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding
- ClinicalTrials.gov ID
- NCT05554965
- Acronym / sponsor ID
- 20220819
- Conditions
- Endoscopic Hemostasis, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Sep 2022 (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.
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
Detailed description
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: PropofolThe control group was sedated with propofol |
| Remimazolam besylate | Experimental | Drug: Remimazolam besylateThe experimental group was given remazolam besylate for sedation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with bleeding from ruptured esophageal and gastric varices
- Endoscopic hemostatic treatment was performed
- Body Mass Index(BMI)18～28kg/m2
Key exclusion criteria (5 listed)
- History or evidence of increased risk of sedation/anesthesia;
- Pregnant and lactating women;
- Have participated in other drug trials within 30 days prior to enrollment;
- those with contraindications to propofol, opioids and their remedies;
- Unwilling to sign informed consent.
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 |
|---|---|---|
| PropofolAlso: Active ComparatorRemifentanil maintenance analgesic dose was 1.2-9 μg/kg/h. If the CPOT score ≥3 at the time of maintenance administration, dose adjustment can be considered. Propofol was used for sedation at a loading dose of 0.5mg/kg and a maintenance dose of 1.5mg/kg/h. | Drug | propofol |
| Remimazolam besylateAlso: ExperimentalRemifentanil was administered at a maintenance dose of 1.2-9 μg/kg/h for analgesia. If CPOT score ≥3 during maintenance administration, dose adjustment could be considered. For sedation, remazolam besylate was given a load of 0.1-0.2mg/kg and a maintenance dose of 0.1-0.3mg/kg/h. | Drug | Remimazolam besylate |
Primary outcome
Sedation scores
Time frame: From the begin to 48 hours after procedure
sedation scores were performed during administration,Richmond Agitation-Sedation Scale（RASS）1~-2 was defined as compliance,Otherwise, sedation was considered inadequate
2 secondary outcomes
Rate of adverse events
Time frame: Within 2 hours from the start of administration to the end of administration
Vital signs
Time frame: From the begin to 48 hours after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Yes. All data will be shared with team members
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Remimazolam besylate in people with Endoscopic Hemostasis and Sedation, run by Renmin Hospital of Wuhan University 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 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang (15927142942, 410669243@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation scores (time frame: From the begin to 48 hours after procedure). 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 10 Nov 2022.