Trial · NCT07908121
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
NCT07908121, Not applicable, Recruiting, Nanjing First Hospital, Nanjing Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial. Trials, record NCT07908121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
- NCT number
- NCT07908121
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 600 participants, estimated
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Conditions
- Delirium - Postoperative
- Interventions
- Remimazolam Tosylate, Propofol
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Postoperative Delirium Within 7 Days After Surgery | 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 |
| Secondary | Severity of Postoperative Delirium | From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first. | 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. |
| Secondary | Duration of Postoperative Delirium | From postoperative ICU admission and randomization until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first. | 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. |
| Secondary | Proportion of RASS Assessments Within the Target Sedation Range | From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first. | 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. |
| Secondary | Average Real Variability of Mean Arterial Pressure During Sedation | From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first. | 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. |
| Secondary | Time-Weighted Hypotension Burden Below a Mean Arterial Pressure of 65 mmHg During Sedation | From initiation of study drug infusion until discontinuation of study sedation or ICU discharge, whichever occurs first. | 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. |
| Secondary | Postoperative Pain Scores | From randomization after postoperative ICU admission until 168 hours after the end of surgery, hospital discharge, or death, whichever occurs first. | 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. |
| Secondary | Length of ICU Stay | From the first postoperative ICU admission until the first transfer out of the ICU. | 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 |
| Secondary | In-Hospital Mortality | From randomization until discharge from the index hospitalization or in-hospital death. | The number and proportion of randomized participants who die during the index hospitalization will be recorded and compared between treatment groups. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908121
GET https://conductscience.org/api/trials/v1/NCT07908121/registered