An observational study in Postoperative Delirium, sponsored by Shusheng Li. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Shusheng Li · Observational
This observational study evaluated the association between intraoperative dexmedetomidine use and postoperative delirium (POD) in adults undergoing cardiac surgery with cardiopulmonary bypass (CPB). The study included two linked clinical components. First, routinely collected clinical data from patients undergoing cardiac surgery with CPB at three campuses of Tongji Hospital between January 2015 and December 2022 were analyzed to evaluate the dexmedetomidine-POD association. Second, perioperative plasma samples and clinical data from a prospective observational cohort enrolled between April 2023 and September 2024 were used to characterize perioperative matrix metalloproteinase-8 (MMP-8) dynamics and their associations with intraoperative dexmedetomidine use and POD. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol.
This hospital-based observational study comprised two linked clinical components designed to evaluate the association between intraoperative dexmedetomidine use and postoperative delirium (POD) after cardiac surgery with cardiopulmonary bypass (CPB) and to explore the clinical relevance of perioperative matrix metalloproteinase-8 (MMP-8) responses.
The first component was a retrospective multicampus cohort study using routinely collected clinical data from three campuses of Tongji Hospital. Adult patients undergoing cardiac surgery with CPB between January 2015 and December 2022 were screened according to predefined eligibility criteria. The primary exposure was intraoperative dexmedetomidine administration by continuous intravenous infusion, ascertained from anesthesia records. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol. The primary outcome was POD occurring within 7 days after surgery. Documented POD diagnoses were accepted as confirmed events; when no explicit diagnosis was documented, postoperative medical and nursing records were retrospectively reviewed by trained anesthesiologists and intensivists blinded to intraoperative dexmedetomidine exposure. Secondary outcomes included in-hospital mortality and hospital length of stay. Multivariable regression, propensity score matching, subgroup and interaction analyses, and E-value analysis were used to evaluate the robustness of the dexmedetomidine-POD association.
The second component used archived plasma samples and linked clinical data from a previously established prospective observational cohort of adults undergoing cardiac surgery with CPB who were enrolled between April 2023 and September 2024. In the original cohort, intraoperative dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. POD within 7 days after surgery was prospectively assessed, and participants were followed until hospital discharge. Plasma samples had been collected preoperatively, at the end of surgery, and 24 h postoperatively and stored for subsequent analyses. The original prospective cohort enrollment and perioperative biospecimen collection were approved by the Medical Ethics Committee of Tongji Hospital under Approval No. TJ-IRB20231224. The current study, including secondary analyses of archived clinical data and plasma samples, was subsequently approved under Approval No. TJ-IRB202603077. Archived plasma samples were analyzed for MMP-8, and perioperative MMP-8 levels and changes were evaluated in relation to dexmedetomidine exposure and POD. Additional analyses assessed the discriminatory value of perioperative MMP-8 measures for POD and their potential statistical mediating role in the association between intraoperative dexmedetomidine use and POD.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's enrollment of 5,688 is above the median of 162 across 279 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Shusheng Li is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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The study population consisted of adults aged 18 years or older who underwent cardiac surgery with cardiopulmonary bypass. The retrospective cohort included eligible patients treated at three campuses of Tongji Hospital between January 2015 and December 2022. The prospective biomarker cohort consisted of participants enrolled between April 2023 and September 2024 for whom archived perioperative plasma samples and linked clinical data were available.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and received intraoperative dexmedetomidine by continuous intravenous infusion as part of routine anesthetic care. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and was not assigned by the study protocol.
Drug: Dexmedetomidine
Patients in the retrospective multicampus cohort who underwent cardiac surgery with cardiopulmonary bypass between January 2015 and December 2022 and did not receive intraoperative dexmedetomidine.
Participants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and received intraoperative dexmedetomidine as part of routine anesthetic care. Dexmedetomidine use was determined by the treating anesthesiologist and was not influenced by the study investigators. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses.
Drug: Dexmedetomidine
Participants in the previously established prospective observational cohort who underwent cardiac surgery with cardiopulmonary bypass between April 2023 and September 2024 and did not receive intraoperative dexmedetomidine. Archived perioperative plasma samples from these participants were used for the present MMP-8 analyses.
Intraoperative dexmedetomidine administration during cardiac surgery with cardiopulmonary bypass was an observed clinical exposure. The decision to administer dexmedetomidine, including its dose, timing, and duration, was made by the treating anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned or standardized by the study protocol.
Incidence of Postoperative Delirium
The number and proportion of participants who experienced at least one episode of postoperative delirium within 7 days after surgery. In the retrospective cohort, POD was ascertained from postoperative medical and nursing records using adapted DSM-5 criteria, with blinded review when no explicit diagnosis was documented. In the prospective cohort, POD was assessed prospectively by trained anesthesiologists and intensivists using the CAM-ICU.
Time frame: From the end of surgery through postoperative day 7
Hospital Length of Stay
The number of calendar days from hospital admission to hospital discharge during the index hospitalization.
Time frame: From hospital admission through hospital discharge during the index hospitalization, an average of approximately 3 weeks.
In-Hospital All-Cause Mortality
The number and proportion of participants who died from any cause during the index hospitalization after cardiac surgery.
Time frame: From the end of surgery until death or hospital discharge, whichever occurred first, an average of approximately 3 weeks.
Plasma MMP-8 Level Preoperatively
Plasma MMP-8 concentration measured in archived plasma samples collected before surgery and reported in ng/mL
Time frame: Preoperatively
Plasma Matrix Metalloproteinase-8 Level at the End of Surgery
Plasma matrix metalloproteinase-8 (MMP-8) concentration measured in archived plasma samples collected at the end of surgery and reported in ng/mL.
Time frame: At the end of surgery
Plasma Matrix Metalloproteinase-8 Level at 24 Hours Postoperatively
Plasma matrix metalloproteinase-8 (MMP-8) concentration measured in archived plasma samples collected 24 hours after surgery and reported in ng/mL.
Time frame: At 24 hours after surgery
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication, together with relevant analytic code, may be made available upon reasonable request to the corresponding author, subject to review by the study team and compliance with institutional ethics, data governance, and participant privacy requirements.
Supporting information: Analytic code
Time frame: Data and supporting information may be made available after publication upon reasonable request to the corresponding author. Availability will be considered on a case-by-case basis, subject to review by the study team and applicable institutional ethics, data governance, and participant privacy requirements.
Access criteria: Requests from qualified researchers for scientifically appropriate purposes will be considered by the corresponding author and study team. Access will be granted only after review of the proposed use and, where applicable, approval under institutional ethics and data governance requirements. A data-use agreement may be required.
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Oct 2024, 18 months.
Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 18 months is below that.
Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shusheng Li