Delirium - PostoperativeNCT07908121
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
A study testing Remimazolam Tosylate and Propofol in people with Delirium - Postoperative, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study aims to compare the efficacy and safety of remimazolam tosylate and propofol for postoperative sedation in patients aged 65 years or older undergoing cardiac surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative
- 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
- 600 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 1. Age ≥65 years. 2. Undergoing elective cardiac surgery with cardiopulmonary bypass, including coronary artery bypass grafting (CABG), valve surgery, or combined CABG and valve surgery.
- 3. Admission to the cardiac surgery intensive care unit (ICU) after surgery, with an anticipated need for invasive mechanical ventilation and continuous sedation for at least 2 hours.
- 4. Written informed consent obtained from the participant or their legally authorized representative.
- 5. No delirium identified during the preoperative assessment. Exclusion Criteria
- Emergency or salvage cardiac surgery.
- Heart transplantation, ventricular assist device implantation, surgery for aortic dissection requiring deep hypothermic circulatory arrest, or other cardiac procedures outside the scope of this study.
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- Severe psychiatric disorders, diagnosed Alzheimer's disease or dementia, or preoperative delirium.
- Severe alcohol use disorder or a history of severe alcohol misuse.
- Previous cerebrovascular events or other conditions causing severe visual, hearing, or communication impairment that would prevent reliable delirium assessment despite appropriate assistance.
- Known hypersensitivity or contraindications to either study drug or its excipients, or severe hepatic or renal failure.
- Decompensated acute circulatory failure or hemodynamic instability at the time of randomization.
- Concurrent participation in another interventional clinical trial that could affect the primary outcome.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shu li Zhao, 025-52271000, shulizhao79@163.com
About this study
Official title: Effects of Remimazolam Tosylate Versus Propofol for Postoperative Sedation on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective, Double-Blind, Randomized Controlled Trial
This study aims to compare the efficacy and safety of remimazolam tosylate and propofol for postoperative sedation in patients aged 65 years or older undergoing cardiac surgery with cardiopulmonary bypass. Postoperative delirium (POD) is a common complication in older patients after cardiac surgery and may adversely affect postoperative recovery and clinical outcomes. Whether remimazolam tosylate reduces the incidence of POD compared with propofol under standardized sedation and analgesia protocols remains uncertain.
This is a single-center, prospective, randomized, double-blind, double-dummy, active-controlled superiority trial. A total of 600 eligible patients will be randomized in a 1:1 ratio to receive remimazolam tosylate or propofol for continuous sedation in the cardiac surgery intensive care unit (ICU). In both groups, the infusion rate will be titrated to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -2 to 0, with standardized analgesia and postoperative care.
Read more
The primary outcome is the incidence of POD within 7 days after surgery. Delirium will be assessed using the Confusion Assessment Method for the ICU (CAM-ICU) in patients who are intubated or unable to communicate verbally, and the Chinese version of the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM-CN) in patients who are able to communicate.
Secondary clinical outcomes include time to first delirium, delirium duration and severity, achievement of the target sedation level, pain scores, rescue sedative use, time to extubation, ICU length of stay, hospital length of stay, and safety outcomes, including hypotension, bradycardia, and vasopressor use.
This study aims to determine whether remimazolam tosylate reduces the incidence of POD compared with propofol in older patients after cardiac surgery. The findings may provide clinical evidence to guide postoperative sedative selection and help improve delirium prevention and postoperative recovery in this population.
- Conditions
- Delirium - Postoperative
- Being tested
- Remimazolam Tosylate, Propofol
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosylateDrug
Following postoperative ICU admission and confirmation of eligibility, participants will be randomized to the remimazolam tosylate group. Remimazolam tosylate will be administered by continuous intravenous infusion at a rate of 0.2-1 mg/kg/h. The infusion rate will be titrated according to the Richmond Agitation-Sedation Scale (RASS) to maintain a target score of -2 to 0 until the patient meets the criteria for ventilator weaning.
PropofolDrug
Propofol will be administered by continuous intravenous infusion at a rate of 1-4 mg/kg/h, with the same target Richmond Agitation-Sedation Scale (RASS) score as the intervention group (-2 to 0).
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam tosylate | Experimental | Not described Receives: Drug: Remimazolam Tosylate |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium Within 7 Days After Surgery
The primary outcome is the occurrence of at least one episode of postoperative delirium (POD) within 7 days after surgery. The observation period extends to 168 hours after the end of surgery. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used for patients who are intubated or unable to communicate verbally in the ICU. The Chinese version of the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM-CN) will be used for extubated ICU patients who are able to communicate and for patients in the general ward. Assessments will be performed daily at 07:00 and 19:00 in the ICU and once daily after transfer to the general ward. Any valid positive assessment will indicate POD. Assessments that cannot be completed because of coma, deep sedation, or other reasons will be recorded as unevaluable rather than negative. Outcomes for participants discharged early or who die before completion of the observation period will be handled according to the pr
Measured: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Secondary outcomes (8)
Severity of Postoperative Delirium
Delirium severity will be assessed using the CAM-ICU-7 in ICU patients, with scores ranging from 0 to 7, and the RAW-3DCAM-S in patients able to communicate, with scores ranging from 0 to 20. Scores from the two instruments will be reported separately and will not be directly combined. Scores will be recorded only when the corresponding assessment instrument can be validly administered.
Measured: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Duration of Postoperative Delirium
The duration of postoperative delirium will be determined from delirium assessment records during the postoperative observation period according to prespecified criteria. Periods during which delirium cannot be assessed because of coma, deep sedation, or other reasons will not automatically be considered delirium-free periods.
Measured: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Proportion of RASS Assessments Within the Target Sedation Range
Sedation depth during study sedation in the ICU will be assessed using the Richmond Agitation-Sedation Scale (RASS). The target range is -2 to 0. The outcome is the proportion of valid RASS assessments within the target range among all valid RASS assessments.
Measured: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Average Real Variability of Mean Arterial Pressure During Sedation
Average real variability (ARV) of mean arterial pressure (MAP) will be calculated from valid continuous or repeated blood pressure measurements during study sedation. ARV is defined as the mean absolute difference between consecutive valid MAP measurements. Obvious artifacts will be excluded according to prespecified data-cleaning rules. Valid monitoring duration and the proportion of missing data will be recorded.
Measured: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Time-Weighted Hypotension Burden Below a Mean Arterial Pressure of 65 mmHg During Sedation
The area representing mean arterial pressure (MAP) below 65 mmHg during study sedation will be calculated and divided by the valid monitoring time to obtain the time-weighted hypotension burden. This measure will be used to compare the severity and cumulative burden of hypotension between treatment groups. Missing or invalid monitoring periods will not be treated as periods of normal blood pressure.
Measured: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Postoperative Pain Scores
Pain intensity will be assessed using the Numeric Rating Scale (NRS) in patients able to communicate. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Patients unable to report pain will be recorded as unevaluable rather than assigned a score of zero.
Measured: From randomization after postoperative ICU admission until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Length of ICU Stay
The duration from the first postoperative ICU admission until the first transfer out of the ICU will be recorded in hours or days. If a participant is readmitted to the ICU after transfer out, whether subsequent ICU stays are included in the total duration will be determined according to the prespecified statistical analysis plan
Measured: From the first postoperative ICU admission until the first transfer out of the ICU.
In-Hospital Mortality
The number and proportion of randomized participants who die during the index hospitalization will be recorded and compared between treatment groups.
Measured: From randomization until discharge from the index hospitalization or in-hospital death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start5 Sep 2026
- Primary completion23 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HONG LIANG, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908121
- Sponsor's protocol ID
- KY20260820-09
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study involves clinical records, perioperative information, and delirium assessment data. To protect participants' privacy and personal information and to comply with ethical approval requirements, informed consent provisions, and institutional data governance policies, sharing of individual-level data with external researchers is not currently planned. Study findings will be made publicly available through scientific publications and other means in the form of aggregated data. If sharing of de-identified individual participant data is considered in the future, it will be further evaluated in accordance with ethical review requirements, participant informed consent, and institutional data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam Tosylate Versus Propofol for Postoperative Sedation on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07908121
- Acronym / sponsor ID
- KY20260820-09
- Conditions
- Delirium - Postoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (actual)
- Primary completion
- 23 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
This study aims to compare the efficacy and safety of remimazolam tosylate and propofol for postoperative sedation in patients aged 65 years or older undergoing cardiac surgery with cardiopulmonary bypass. Postoperative delirium (POD) is a common complication in older patients after cardiac surgery and may adversely affect postoperative recovery and clinical outcomes. Whether remimazolam tosylate reduces the incidence of POD compared with propofol under standardized sedation and analgesia protocols remains uncertain.
This is a single-center, prospective, randomized, double-blind, double-dummy, active-controlled superiority trial. A total of 600 eligible patients will be randomized in a 1:1 ratio to receive remimazolam tosylate or propofol for continuous sedation in the cardiac surgery intensive care unit (ICU). In both groups, the infusion rate will be titrated to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -2 to 0, with standardized analgesia and postoperative care.
The primary outcome is the incidence of POD within 7 days after surgery. Delirium will be assessed using the Confusion Assessment Method for the ICU (CAM-ICU) in patients who are intubated or unable to communicate verbally, and the Chinese version of the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM-CN) in patients who are able to communicate.
Secondary clinical outcomes include time to first delirium, delirium duration and severity, achievement of the target sedation level, pain scores, rescue sedative use, time to extubation, ICU length of stay, hospital length of stay, and safety outcomes, including hypotension, bradycardia, and vasopressor use.
This study aims to determine whether remimazolam tosylate reduces the incidence of POD compared with propofol in older patients after cardiac surgery. The findings may provide clinical evidence to guide postoperative sedative selection and help improve delirium prevention and postoperative recovery in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam tosylate | Experimental | Drug: Remimazolam Tosylate |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 1. Age ≥65 years. 2. Undergoing elective cardiac surgery with cardiopulmonary bypass, including coronary artery bypass grafting (CABG), valve surgery, or combined CABG and valve surgery.
- 3. Admission to the cardiac surgery intensive care unit (ICU) after surgery, with an anticipated need for invasive mechanical ventilation and continuous sedation for at least 2 hours.
- 4. Written informed consent obtained from the participant or their legally authorized representative.
- 5. No delirium identified during the preoperative assessment. Exclusion Criteria
- Emergency or salvage cardiac surgery.
Key exclusion criteria (0 listed)
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 TosylateFollowing postoperative ICU admission and confirmation of eligibility, participants will be randomized to the remimazolam tosylate group. Remimazolam tosylate will be administered by continuous intravenous infusion at a rate of 0.2-1 mg/kg/h. The infusion rate will be titrated according to the Richmond Agitation-Sedation Scale (RASS) to maintain a target score of -2 to 0 until the patient meets the criteria for ventilator weaning. | Drug | Remimazolam tosylate |
| PropofolPropofol will be administered by continuous intravenous infusion at a rate of 1-4 mg/kg/h, with the same target Richmond Agitation-Sedation Scale (RASS) score as the intervention group (-2 to 0). | Drug | Propofol |
Primary outcome
Incidence of Postoperative Delirium Within 7 Days After Surgery
Time frame: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
The primary outcome is the occurrence of at least one episode of postoperative delirium (POD) within 7 days after surgery. The observation period extends to 168 hours after the end of surgery. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used for patients who are intubated or unable to communicate verbally in the ICU. The Chinese version of the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM-CN) will be used for extubated ICU patients who are able to communicate and for patients in the general ward. Assessments will be performed daily at 07:00 and 19:00 in the ICU and once daily after transfer to the general ward. Any valid positive assessment will indicate POD. Assessments that cannot be completed because of coma, deep sedation, or other reasons will be recorded as unevaluable rather than negative. Outcomes for participants discharged early or who die before completion of the observation period will be handled according to the pr
8 secondary outcomes
Severity of Postoperative Delirium
Time frame: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Duration of Postoperative Delirium
Time frame: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Proportion of RASS Assessments Within the Target Sedation Range
Time frame: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Average Real Variability of Mean Arterial Pressure During Sedation
Time frame: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Time-Weighted Hypotension Burden Below a Mean Arterial Pressure of 65 mmHg During Sedation
Time frame: From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first.
Postoperative Pain Scores
Time frame: From randomization after postoperative ICU admission until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
Length of ICU Stay
Time frame: From the first postoperative ICU admission until the first transfer out of the ICU.
In-Hospital Mortality
Time frame: From randomization until discharge from the index hospitalization or in-hospital death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided. This study involves clinical records, perioperative information, and delirium assessment data. To protect participants' privacy and personal information and to comply with ethical approval requirements, informed consent provisions, and institutional data governance policies, sharing of individual-level data with external researchers is not currently planned. Study findings will be made publicly available through scientific publications and other means in the form of aggregated data. If sharing of de-identified individual participant data is considered in the future, it will be further evaluated in accordance with ethical review requirements, participant informed consent, and institutional data governance policies.
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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.
1 site 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 Delirium - Postoperative, run by Nanjing First Hospital, Nanjing Medical 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 30 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact liang hong, doctor (+86 13914755401, hlblade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium Within 7 Days After Surgery (time frame: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.). 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 30 Oct 2026.