HypoxiaNCT04727034
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
A study testing Remimazolam tosylate and Propofol in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 5 sites in China.
Trial summary
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypoxia, Gastric Cancer, Sedation Complication
- What is being tested?
- Remimazolam tosylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 5 sitesChina
- Study dates
- 2 Mar 2021to 1 Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2<BMI<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.
Who cannot join
- Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);
- Patients who intend to undergo tracheal intubation;
- It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
- Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
- Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
- Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal);
Show all 14Show fewer
- There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur);
- Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg);
- Sitting systolic blood pressure ≤90 mmHg during the screening period;
- Women who are pregnant or breastfeeding;
- Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
- Participated in other drug clinical trials as subjects in the past 3 months;
- The investigator believes that it is not appropriate to participate in this trial;
- A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Affiliated Hospital of Jiaxing University
Jiaxing
Ming Yao, PhD, 13758394990, jxyaoming@163.com
- Recruiting
The Second Affifiliated Hospital of Jiaxing University
Jiaxing
Hongmei zhou, 13867300139
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
shibiao chen, 13870892918, chenlaoshi1111@163.com
- Recruiting
Renji Hospital
Shanghai, Shanghai, China, 200127
Diansan Su, Dr., +862168383702, diansansu@yahoo.com
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai, China, 200127
Xiangrui D Wang, Dr., 13701901953
About this study
Official title: A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
- Being tested
- Remimazolam tosylate, Propofol
- Keywords
- Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam, Propofol
- Medical subject headings
- Hypoxia, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam tosylateDrug
Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
PropofolDrug
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Propofol（1.5mg/kg） Receives: Drug: Propofol |
| Test group 1（Remimazolam tosylate 0.15mg/kg） | Experimental | Remimazolam tosylate 0.15mg/kg Receives: Drug: Remimazolam tosylate |
| Test group 2（Remimazolam tosylate 0.2mg/kg） | Experimental | Remimazolam tosylate 0.2mg/kg Receives: Drug: Remimazolam tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
- Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (7)
Sedation induction time
induction time
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Sedation recovery time
recovery time
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of drug injection pain
drug injection pain
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Doctor satisfaction and patient satisfaction
There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;
Sedation/Anaesthesia Discharge Rating Scale
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of hypoxia during sedation
(75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events assessed by the World SIVA adverse sedation event reporting tool
other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start2 Mar 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
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 HypoxiaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai East Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727034
- Sponsor's protocol ID
- sudiansan1215
- Status last verified
- Oct 2022
- First submitted
- 14 Jan 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0.
PubMed 36510290
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Parallel Controlled Clinical Study on the Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy
- ClinicalTrials.gov ID
- NCT04727034
- Acronym / sponsor ID
- sudiansan1215
- Keywords
- Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam, Propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai East Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, The First Affiliated Hospital of Nanchang University
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 27 Jan 2021 (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.
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: PropofolPropofol（1.5mg/kg） |
| Test group 1（Remimazolam tosylate 0.15mg/kg） | Experimental | Drug: Remimazolam tosylateRemimazolam tosylate 0.15mg/kg |
| Test group 2（Remimazolam tosylate 0.2mg/kg） | Experimental | Drug: Remimazolam tosylateRemimazolam tosylate 0.2mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2<BMI<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.
Key exclusion criteria (14 listed)
- Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);
- Patients who intend to undergo tracheal intubation;
- It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
- Anemia or thrombocytopenia,( Hb<90g/L, PLT<80×109/L);
- Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
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 |
|---|---|---|
| Remimazolam tosylateRemazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia. | Drug | Test group 1（Remimazolam tosylate 0.15mg/kg）, Test group 2（Remimazolam tosylate 0.2mg/kg） |
| PropofolPropofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. | Drug | Control group |
Primary outcome
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
1) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated
7 secondary outcomes
Sedation induction time
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Sedation recovery time
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of drug injection pain
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Doctor satisfaction and patient satisfaction
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of hypoxia during sedation
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events assessed by the World SIVA adverse sedation event reporting tool
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 36510290Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam tosylate and Propofol in people with Hypoxia and Gastric Cancer, run by RenJi Hospital at 5 sites 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 1 inclusion and 14 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). 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 NCT04727034, 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 12 Oct 2022.