AnestheticsPhase 4NCT05406102
Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy
A Phase 4 study testing Remimazolam and Propofol group in people with Anesthetics and Recovery, run by First Affiliated Hospital Xi'an Jiaotong University at 9 sites in China.
Trial summary
Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anesthetics, Recovery, Drug Effect
- What is being tested?
- Remimazolam and Propofol group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 9 sitesChina
- Study dates
- 10 Jul 2022to 1 Jun 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60, no gender limitation;
- Patients receiving gastroscopy or gastrointestinal endoscope;
- ASA physical status score of I to III;
- 18 kg/m² < BMI < 30kg/m²;
- They clearly understand and voluntarily participate in the study and sign informed consent
Who cannot join
- Endoscopic diagnosis and treatment techniques with complex operation are required;
- Patients with respiratory management difficulties;
- Anemia or Thrombocytopenia;
- Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
- Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);
- Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;
- Participated in clinical trials of other drugs as a subject within the last 3 months;
- The investigator considered the patients unfit to participate in the trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
The First Hospital of Lanzhou University
Lanzhou, Gansu
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 029710061
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 029710068
Xian Yang Central Hospital
Xi'an, Shaanxi
Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
Xianyang, Shaanxi, 029712000
Qinghai University Affiliated Hospital
Xining, Qinghai
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Xinjiang, Xinjiang
Affiliated Tumor Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study
Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports.
In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.
Read the detailed description
Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation < 90%, the incidence of respiratory rate < 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.
- Conditions
- Anesthetics, Recovery, Drug Effect, Safety, Psychotropic Drugs, Anesthetics, Intravenous
- Being tested
- Remimazolam, Propofol group
- Keywords
- Remimazolam, Elderly, Endoscopes, Gastrointestinal, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called experimental
Patients received an initial dose of 0.1mg/kg of remimazolam (add to 0.05 mg/kg top-ups doses to a total of up to five times within 15minutes).
Propofol groupDrug
Also called active comparator
Patients received an initial dose of 1.5mg/kg of propofol(add to 0.5 mg/kg top-ups doses to a total of up to five times within 15minutes).
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Patients were slowly injected of 0.08 ug/kg of sufentanil. Patients received remimazolam 0.1mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. Receives: Drug: Remimazolam |
| Propofol group | Active comparator | Patients were slowly injected of 0.08 ug/kg of sufentanil for 1 min during the examination.Patients received Propofol 1.5mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. Receives: Drug: Propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyoxemia
The proportion of blood oxygen saturation < 90%.
Measured: two hours
Secondary outcomes (10)
Incidence of respiratory depression
The incidence of respiratory rate < 8 times/min
Measured: two hours
Incidence of hypotension
The incidence of systolic blood pressure decreased by more than 20% before sedation or systolic blood pressure decreased to ≤ 80 mmHg.
Measured: two hours
The time of Improved Aldrete≥9
improved Aldrete≥9 was evaluated every 1 min after the last administration, and the time from the last administration to improved Aldrete score ≥9 .
Measured: two hours
The time of discharge score ≥9
the discharge score was evaluated every 3 minutes after the modified Aldrete≥9, and the time from the last administration to the discharge score ≥9.
Measured: two hours
Postoperative cognitive decline rate
Changes in MOCA score before and after surgery
Measured: two hours
Incidence of postoperative amnesia
incidence of anterograde and retrograde amnesia
Measured: two hours
Incidence of postoperative anxiety
incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score ≥ 10
Measured: two hours
Incidence of postoperative vertigo
incidence of vertigo patients
Measured: two hours
Incidence of postoperative pain
incidence of patients with visual analogue scale (VAS) ≥ 4
Measured: two hours
Adverse events
abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start10 Jul 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnestheticsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406102
- Sponsor's protocol ID
- XJTUIAF2020LSK-213
- Status last verified
- Dec 2021
- First submitted
- 1 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05406102
- Acronym / sponsor ID
- XJTUIAF2020LSK-213
- Conditions
- Anesthetics, Recovery, Drug Effect, Safety, Psychotropic Drugs, Anesthetics, Intravenous
- Keywords
- Remimazolam, Elderly, Endoscopes, Gastrointestinal, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 6 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.
Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports.
In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.
Detailed description
Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation < 90%, the incidence of respiratory rate < 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamPatients were slowly injected of 0.08 ug/kg of sufentanil. Patients received remimazolam 0.1mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. |
| Propofol group | Active comparator | Drug: Propofol groupPatients were slowly injected of 0.08 ug/kg of sufentanil for 1 min during the examination.Patients received Propofol 1.5mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥60, no gender limitation;
- Patients receiving gastroscopy or gastrointestinal endoscope;
- ASA physical status score of I to III;
- 18 kg/m² < BMI < 30kg/m²;
- They clearly understand and voluntarily participate in the study and sign informed consent
Key exclusion criteria (8 listed)
- Endoscopic diagnosis and treatment techniques with complex operation are required;
- Patients with respiratory management difficulties;
- Anemia or Thrombocytopenia;
- Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
- Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);
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: experimentalPatients received an initial dose of 0.1mg/kg of remimazolam (add to 0.05 mg/kg top-ups doses to a total of up to five times within 15minutes). | Drug | Remimazolam group |
| Propofol groupAlso: active comparatorPatients received an initial dose of 1.5mg/kg of propofol(add to 0.5 mg/kg top-ups doses to a total of up to five times within 15minutes). | Drug | Propofol group |
Primary outcome
Incidence of hyoxemia
Time frame: two hours
The proportion of blood oxygen saturation < 90%.
10 secondary outcomes
Incidence of respiratory depression
Time frame: two hours
Incidence of hypotension
Time frame: two hours
The time of Improved Aldrete≥9
Time frame: two hours
The time of discharge score ≥9
Time frame: two hours
Postoperative cognitive decline rate
Time frame: two hours
Incidence of postoperative amnesia
Time frame: two hours
Incidence of postoperative anxiety
Time frame: two hours
Incidence of postoperative vertigo
Time frame: two hours
Incidence of postoperative pain
Time frame: two hours
Adverse events
Time frame: two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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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.
Qiang Wang study chair
First Affiliated Hospital Xi'an Jiaotong University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Propofol group in people with Anesthetics and Recovery, run by First Affiliated Hospital Xi'an Jiaotong University at 9 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 5 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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 Qiang Wang (0086-02985323646, dr.wangqiang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hyoxemia (time frame: two hours). 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 1 Jul 2022.