Induction of AnesthesiaPhase 4NCT05429086
Explore the Advantages of Remimazolam Used on Gastroscopy
A Phase 4 study testing Remimazolam combined propofol, Remimazolam and Propofol in people with Induction of Anesthesia, run by Sichuan Provincial People's Hospital.
Trial summary
There are many different types of intravenous anesthetics used in gastroscopy, but each type of drug has its advantages and disadvantages,remimazolam is a novel ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil,remimazolam may be… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Induction of Anesthesia
- What is being tested?
- Remimazolam combined propofol, Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Aug 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 who are to undergo painless gastroscopy
- Patients aged 18 - 80 years, regardless of gender
- 18 < BMI < 30 kg/m2.
- American Society of Anesthesiologists (ASA) classification of I-III.
Who cannot join
- Preoperative hypertensive patients >180/110 mm Hg or hypotensive patients <80/50 mm Hg.
- Heart rate <50 beats/min.
- A history of acute inflammation of the respiratory tract that has not been cured within 2 weeks; severe metabolic diseases of the heart, brain, lungs, liver, kidneys and diabetes mellitus; previous heart attack, severe myocardial, ischemia, severe atrioventricular block
- Those who may have or have had a difficult airway or a history of recovery from abnormal surgical anesthesia
- Patients with significant electrolyte disturbances such as hyperkalemia
- Patients with a history of long-term use of immunosuppressive agents such as hormones or adrenal cortical suppression
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- Patients with known allergy to emulsions and opioids
- Those with combined use of other sedative and analgesic drugs within the preoperative period (including injections, oral and use of related proprietary Chinese medicines)
- Those suspected of abusing narcotic analgesics or sedatives
- Those who have neuromuscular system diseases, mental diseases, etc. who do not cooperate and cannot communicate.
About this study
Official title: Explore the Advantages of Remimazolam Used on Gastroscopy : A Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study
There are many different types of intravenous anesthetics used in gastroscopy, but each type of drug has its advantages and disadvantages,remimazolam is a novel ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil,remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The purpose of this study was to explore whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.
Read the detailed description
Sedation for gastroscopy is still a topic of debate in the global anesthesia and gastroenterology communities, and the sedation protocols of anesthesiologists and endoscopists vary widely. There are many different types of intravenous anesthetic drugs used in gastroscopy, but each type of drug has its advantages and disadvantages, and the most common protocol in anesthesia practice is an opioid (e.g., fentanyl) combined with a sedative-hypnotic drug (e.g., propofol and midazolam). But these protocols usually have limitations with propofol mainly focusing on respiratory depression and circulatory depression, in which perioperative hypotension should be considered a serious public health problem and should be taken seriously by clinicians, while midazolam has a long onset of action and a long recovery time. Therefore, there is an urgent clinical need for a fast-onset, fast-recovery drug with a high safety profile to solve this current dilemma.
As a new ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil, remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The drug was approved for procedural sedation in 2020, and there are many studies on the use of remimazolam versus propofol in gastrointestinal endoscopy sedation. A non-inferiority clinical study of remimazolam tosilate in the upper gastrointestinal tract showed that remimazolam had a sedation success rate no lower than that of propofol, a longer onset of sedation than propofol, but a shorter time to full consciousness than propofol, and a significantly lower incidence of adverse events than propofol. These findings suggest that remimazolam is indeed safer than propofol, but its depth of sedation may be inferior to that of propofol. For clinical workers, it is also essential to have good depth of sedation while ensuring safety. Therefore, considering the above, we hypothesized that the use of remimazolam in combination with propofol in gastrointestinal endoscopy could meet clinical sedation needs and also reduce the incidence of respiratory depression and circulatory depression, which have not been reported. The purpose of this study was to determine whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.
- Conditions
- Induction of Anesthesia
- Being tested
- Remimazolam combined propofol, Remimazolam, Propofol
- Keywords
- remimazolam, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam combined propofolDrug
Remimazolam combined propofol
RemimazolamDrug
remimazolam only
PropofolDrug
propofol only
| Study group | Role | What they receive |
|---|---|---|
| group remimazolam | Active comparator | The initial dose of remimazolam was 0.2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin; If MOAA/S score > 3 point, additional administration of remimazoalm will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs.
remimazolam supplemental administration: the supplemental dose was 2.5 mg , bolus Receives: Drug: Remimazolam |
| group propofol | Active comparator | The initial dose of propofol was 2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will commence. If subjects' MOAA/S score > 3 point, additional administration of propofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs.
Propofol supplemental administration: the supplemental dose was 0.5mg/kg, bolus. Receives: Drug: Propofol |
| group remimazolam combined propofol | Experimental | The initial dose of remimazolam was 0.1 mg/kg, combined propofol 0.5mg/kg, and the infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin. If subjects' MOAA/S score > 3, additional administration of propofol will be allowed. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation was failure, and the study was recorded and quit. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy, the evaluator decides when to administer additional drugs.
supplemental administration: the supplemental dose was remimazolam 2.5 mg,single dose, bolus. There is no permission to use propofol , unless the MOAA/S score still > 3 after five consecutive dosing supplement Receives: Drug: Remimazolam combined propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
20% lower blood pressure than before the drug was administered
Measured: Day 1
Secondary outcomes (4)
Sedation success time
MOAA/S score ≤ 3
Measured: Day 1
Injection pain
the pain score when give the subjects administration
Measured: Day 1
Orientational force score
ask the participants questions to evaluate
Measured: Day 1
Ataxia Scale
teach the participants some motions , then ask them repeat the motions
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (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 Induction of AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429086
- Sponsor's protocol ID
- HR7056-IIT
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei A, Ma S, Dou Y, Wang X, Wu J, Zhou S, Deng Y, Liu X, Li D, Yang M. The safety and efficacy of remimazolam tosylate combined with propofol in upper gastrointestinal endoscopy: A multicenter, randomized clinical trial. PLoS One. 2023 Aug 3;18(8):e0282930. doi: 10.1371/journal.pone.0282930. eCollection 2023.
PubMed 37535618
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Advantages of Remimazolam Used on Gastroscopy : A Large Sample, Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05429086
- Acronym / sponsor ID
- HR7056-IIT
- Conditions
- Induction of Anesthesia
- Keywords
- remimazolam, propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 23 Jun 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.
There are many different types of intravenous anesthetics used in gastroscopy, but each type of drug has its advantages and disadvantages,remimazolam is a novel ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil,remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The purpose of this study was to explore whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.
Detailed description
Sedation for gastroscopy is still a topic of debate in the global anesthesia and gastroenterology communities, and the sedation protocols of anesthesiologists and endoscopists vary widely. There are many different types of intravenous anesthetic drugs used in gastroscopy, but each type of drug has its advantages and disadvantages, and the most common protocol in anesthesia practice is an opioid (e.g., fentanyl) combined with a sedative-hypnotic drug (e.g., propofol and midazolam). But these protocols usually have limitations with propofol mainly focusing on respiratory depression and circulatory depression, in which perioperative hypotension should be considered a serious public health problem and should be taken seriously by clinicians, while midazolam has a long onset of action and a long recovery time. Therefore, there is an urgent clinical need for a fast-onset, fast-recovery drug with a high safety profile to solve this current dilemma.
As a new ultra-short-acting benzodiazepine with rapid onset and recovery, low circulatory depression, and rapid reversal of sedation by flumazenil, remimazolam may be another relatively ideal sedative-hypnotic option for anesthesiologists and gastrointestinal endoscopists. The drug was approved for procedural sedation in 2020, and there are many studies on the use of remimazolam versus propofol in gastrointestinal endoscopy sedation. A non-inferiority clinical study of remimazolam tosilate in the upper gastrointestinal tract showed that remimazolam had a sedation success rate no lower than that of propofol, a longer onset of sedation than propofol, but a shorter time to full consciousness than propofol, and a significantly lower incidence of adverse events than propofol. These findings suggest that remimazolam is indeed safer than propofol, but its depth of sedation may be inferior to that of propofol. For clinical workers, it is also essential to have good depth of sedation while ensuring safety. Therefore, considering the above, we hypothesized that the use of remimazolam in combination with propofol in gastrointestinal endoscopy could meet clinical sedation needs and also reduce the incidence of respiratory depression and circulatory depression, which have not been reported. The purpose of this study was to determine whether remimazolam combined with propofol is safer and more effective than remimazolam alone or propofol alone in gastrointestinal endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group remimazolam | Active comparator | Drug: RemimazolamThe initial dose of remimazolam was 0.2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin; If MOAA/S score > 3 point, additional administration of remimazoalm will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs. remimazolam supplemental administration: the supplemental dose was 2.5 mg , bolus |
| group propofol | Active comparator | Drug: PropofolThe initial dose of propofol was 2mg/kg, and the intravenous infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will commence. If subjects' MOAA/S score > 3 point, additional administration of propofol will be allowed 1 minute after the end of the initial dose. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation failure was determined, and the study was recorded and quit. The drug was given according to clinical needs and the examination was completed. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy , the evaluator decides when to administer additional drugs. Propofol supplemental administration: the supplemental dose was 0.5mg/kg, bolus. |
| group remimazolam combined propofol | Experimental | Drug: Remimazolam combined propofolThe initial dose of remimazolam was 0.1 mg/kg, combined propofol 0.5mg/kg, and the infusion time was 30s. Within 1 minute (inclusive) of the end of the initial dose: if the subject has achieved sufficient sedation (MOAA/S score ≤3), the gastroscopy will begin. If subjects' MOAA/S score > 3, additional administration of propofol will be allowed. If the MOAA/S score was >3 after 3 consecutive times of addition, sedation was failure, and the study was recorded and quit. Maintenance of sedation after gastroscopy: In order to maintain a certain degree of sedation after gastroscopy, the evaluator decides when to administer additional drugs. supplemental administration: the supplemental dose was remimazolam 2.5 mg,single dose, bolus. There is no permission to use propofol , unless the MOAA/S score still > 3 after five consecutive dosing supplement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are to undergo painless gastroscopy
- Patients aged 18 - 80 years, regardless of gender
- 18 < BMI < 30 kg/m2.
- American Society of Anesthesiologists (ASA) classification of I-III.
Key exclusion criteria (10 listed)
- Preoperative hypertensive patients >180/110 mm Hg or hypotensive patients <80/50 mm Hg.
- Heart rate <50 beats/min.
- A history of acute inflammation of the respiratory tract that has not been cured within 2 weeks; severe metabolic diseases of the heart, brain, lungs, liver, kidneys and diabetes mellitus; previous heart attack, severe myocardial, ischemia, severe atrioventricular block
- Those who may have or have had a difficult airway or a history of recovery from abnormal surgical anesthesia
- Patients with significant electrolyte disturbances such as hyperkalemia
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 combined propofolRemimazolam combined propofol | Drug | group remimazolam combined propofol |
| Remimazolamremimazolam only | Drug | group remimazolam |
| Propofolpropofol only | Drug | group propofol |
Primary outcome
Incidence of hypotension
Time frame: Day 1
20% lower blood pressure than before the drug was administered
4 secondary outcomes
Sedation success time
Time frame: Day 1
Injection pain
Time frame: Day 1
Orientational force score
Time frame: Day 1
Ataxia Scale
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 37535618Wei A, Ma S, Dou Y, Wang X, Wu J, Zhou S, Deng Y, Liu X, Li D, Yang M. The safety and efficacy of remimazolam tosylate combined with propofol in upper gastrointestinal endoscopy: A multicenter, randomized clinical trial. PLoS One. 2023 Aug 3;18(8):e0282930. doi: 10.1371/journal.pone.0282930. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam combined propofol, Remimazolam and Propofol in people with Induction of Anesthesia, run by Sichuan Provincial People's Hospital.
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 4 inclusion and 10 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 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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 hypotension (time frame: Day 1). 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 NCT05429086, 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 23 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.