Efficacy and SafetyPhase 4NCT06690424
Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
A Phase 4 study testing Remimazolam and Propofol in people with Efficacy and Safety, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
the investigators are conducting a clinical study on the efficacy and safety of remimazolam for induction and maintenance of anesthesia in elderly patients. Project number: CRCF-YXFN-202401029, funded by the Red Cross Foundation of China and will take more than 2 years to complete. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Jan 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery for clinically diagnosed thyroid tumors
- Patients with general anesthesia
- Patients requiring endotracheal intubation
- American Society of Anesthesia gradeⅡ to grade Ⅲ
- age 60-75 years old
- body mass index was between 18 and 28
- Patients or their family was clear about the study process and volunteered to participate.
Who cannot join
- Patients with known allergy to remimazolam or with previous history of severe allergy and family history
- Patients with long-term use of narcotic analgesics, sedatives, or non- steroidal anti-inflammatory drugs
- Patients with drug taking, opioid dependence or tolerance
- Patients with combined brain injury or intracranial hypertension
- Patients with severe abnormal function of the heart, lung, liver, kidney and other major organs
- Patients with bradycardia, with a heart rate lower than 55 beats / minute or a high atrioventricular block
Show all 10Show fewer
- Patients with a previous history of allergic disease
- Patients with a previous history of mental illness
- Patients with a foreseeable difficult airway
- The investigator does not consider it appropriate to attend this clinical investigator.
Trial locations and contacts
1 site in 1 country.
About this study
the investigators are conducting a clinical study on the efficacy and safety of remimazolam for induction and maintenance of anesthesia in elderly patients. Project number: CRCF-YXFN-202401029, funded by the Red Cross Foundation of China and will take more than 2 years to complete.
This is a single-center, randomized, controlled clinical study, randomized 60 elderly subjects undergoing general anesthesia for elective surgery. According to the random number method, propofol group (control group, group P) and remimazolam group (experimental group, group R), 30 cases in each group.
By participating in this study, it is possible to make anesthesia induction rapid and stable, stable intraoperative circulation, rapid recovery and safe and comfortable, reduce the Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on, which is conducive to rapid postoperative recovery and reduce hospitalization costs.
Read the detailed description
Research background: Rapid and steady anesthesia induction, stable intraoperative circulation, rapid recovery, safe and comfortable, and few adverse reactions are the goals of anesthesiologists. Accelerating the surgical turnover and improving the efficiency are the clinical problems that need to be solved. Clinical general anesthesia often adopts static inhalation compound anesthesia to give full play to the advantages of intravenous and inhalation anesthesia and reduce their respective adverse reactions. Remimazolam, as a new ultra-short-acting benzodiazepine sedative, is not widely used in elderly patients, but its rapid onset, short time half-life, less accumulation, little cardiopulmonary inhibition, no injection pain, and can be antagonized by flumazenil, showing an irreplaceable advantage.
Study objective: To observe the efficacy and safety of remimazolam for the induction and maintenance of anesthesia in elderly patients, and to provide a new option for anesthesia management in elderly and critically ill patients.
Study method: This topic adopts a single-center, prospective, randomized, controlled research method, and expects to include 60 elderly subjects with general endotracheal anesthesia for elective surgery.
- Conditions
- Efficacy and Safety
- Being tested
- Remimazolam, Propofol
- Keywords
- remimazolam, anesthesia induction, continuous anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called R
remimazolam 0.2mg / kg was injected IV during the induction of anesthesia，and remimazolam 0.3-0.5mg / kg / h was administered IV during anesthesia maintenance.
PropofolDrug
Also called P
Propofol 1.5-2mg / kg was injected IV during the induction of anesthesia，and Propofol 2-3mg / kg / h was administered IV during anesthesia maintenance.
| Study group | Role | What they receive |
|---|---|---|
| group R | Experimental | This group is the experimental group with remimazolam for anesthesia induction and maintenance Receives: Drug: Remimazolam |
| group P | Active comparator | This group is the control group with propofol for anesthesia induction and maintenance Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of induction of anesthesia
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 point within 5 minutes of administration (The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
Measured: At 5 minutes after the onset of anesthesia induction
Secondary outcomes (5)
Supplement rate of the study drug
Number of patients requiring remimazolam supplementation / total number of patients in the experimental group
Measured: During the operation period
Sedation depth
the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score at the different time points (The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
Measured: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Amount of sedative and analgesic drugs used
Amount of sedation and analgesics used per unit time during anesthesia maintenance period
Measured: During anesthesia maintenance period
Hemodynamic index （1）
Heart rate
Measured: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Hemodynamic index （2）
mean arterial pressure
Measured: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start20 Jun 2025
- Primary completion30 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao MB Director of scientific research Department, Doctor, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690424
- Sponsor's protocol ID
- CRCF-YXFN-202401029
- Status last verified
- Oct 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies of the Efficacy and Safety of Remimazolam for Anesthesia Induction and Maintenance in Elderly Patients
- ClinicalTrials.gov ID
- NCT06690424
- Acronym / sponsor ID
- CRCF-YXFN-202401029
- Conditions
- Efficacy and Safety
- Keywords
- remimazolam, anesthesia induction, continuous anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 15 Nov 2024 (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.
the investigators are conducting a clinical study on the efficacy and safety of remimazolam for induction and maintenance of anesthesia in elderly patients. Project number: CRCF-YXFN-202401029, funded by the Red Cross Foundation of China and will take more than 2 years to complete.
This is a single-center, randomized, controlled clinical study, randomized 60 elderly subjects undergoing general anesthesia for elective surgery. According to the random number method, propofol group (control group, group P) and remimazolam group (experimental group, group R), 30 cases in each group.
By participating in this study, it is possible to make anesthesia induction rapid and stable, stable intraoperative circulation, rapid recovery and safe and comfortable, reduce the Incidence of intraoperative awareness, arrhythmia, postoperative delusion, and so on, which is conducive to rapid postoperative recovery and reduce hospitalization costs.
Detailed description
Research background: Rapid and steady anesthesia induction, stable intraoperative circulation, rapid recovery, safe and comfortable, and few adverse reactions are the goals of anesthesiologists. Accelerating the surgical turnover and improving the efficiency are the clinical problems that need to be solved. Clinical general anesthesia often adopts static inhalation compound anesthesia to give full play to the advantages of intravenous and inhalation anesthesia and reduce their respective adverse reactions. Remimazolam, as a new ultra-short-acting benzodiazepine sedative, is not widely used in elderly patients, but its rapid onset, short time half-life, less accumulation, little cardiopulmonary inhibition, no injection pain, and can be antagonized by flumazenil, showing an irreplaceable advantage.
Study objective: To observe the efficacy and safety of remimazolam for the induction and maintenance of anesthesia in elderly patients, and to provide a new option for anesthesia management in elderly and critically ill patients.
Study method: This topic adopts a single-center, prospective, randomized, controlled research method, and expects to include 60 elderly subjects with general endotracheal anesthesia for elective surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group R | Experimental | Drug: RemimazolamThis group is the experimental group with remimazolam for anesthesia induction and maintenance |
| group P | Active comparator | Drug: PropofolThis group is the control group with propofol for anesthesia induction and maintenance |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing surgery for clinically diagnosed thyroid tumors
- Patients with general anesthesia
- Patients requiring endotracheal intubation
- American Society of Anesthesia gradeⅡ to grade Ⅲ
- age 60-75 years old
Key exclusion criteria (10 listed)
- Patients with known allergy to remimazolam or with previous history of severe allergy and family history
- Patients with long-term use of narcotic analgesics, sedatives, or non- steroidal anti-inflammatory drugs
- Patients with drug taking, opioid dependence or tolerance
- Patients with combined brain injury or intracranial hypertension
- Patients with severe abnormal function of the heart, lung, liver, kidney and other major organs
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: Rremimazolam 0.2mg / kg was injected IV during the induction of anesthesia，and remimazolam 0.3-0.5mg / kg / h was administered IV during anesthesia maintenance. | Drug | group R |
| PropofolAlso: PPropofol 1.5-2mg / kg was injected IV during the induction of anesthesia，and Propofol 2-3mg / kg / h was administered IV during anesthesia maintenance. | Drug | group P |
Primary outcome
Success rate of induction of anesthesia
Time frame: At 5 minutes after the onset of anesthesia induction
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 point within 5 minutes of administration (The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
5 secondary outcomes
Supplement rate of the study drug
Time frame: During the operation period
Sedation depth
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Amount of sedative and analgesic drugs used
Time frame: During anesthesia maintenance period
Hemodynamic index （1）
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
Hemodynamic index （2）
Time frame: At the beginning of induction (T0); bispectral index at 60 (T1); at 1minute after endotracheal intubation (T2); at surgical skin incision (T3), 30 minutes after the start of surgery(T4), at the end of surgery (T5), and 1minute (T6) after extubation
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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Xiao MB Director of scientific research Department, Doctor principal investigator
Affiliated Hospital of Nantong University
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 Remimazolam and Propofol in people with Efficacy and Safety, run by Affiliated Hospital of Nantong 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 7 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: finished, as of the sponsor's last update on 6 Apr 2026. 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?
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?
Success rate of induction of anesthesia (time frame: At 5 minutes after the onset of anesthesia induction). 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 6 Apr 2026.