An interventional study of Remimazolam Tosylate and Propofol in Delirium - Postoperative, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 65 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Prevention
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.
795 studies on the registry are indexed under Emergence Delirium; 257 are open to participants now.
This study's planned enrollment of 600 is above the median of 120 across 496 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
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
Drug: Remimazolam Tosylate
Drug: Propofol
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.
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).
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
Time frame: From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first.
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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
Time frame: 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.
Time frame: From randomization until discharge from the index hospitalization or in-hospital death.
Plan to share: 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.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.
Of 197 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 15 months is below that.
Counting every sponsor, half of 198 studies reached it within 21 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Remimazolam tosylate
Nanjing First Hospital, Nanjing Medical University →