Effect of Perioperative Dezocine Administration on Postoperative Delirium in Elderly Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial
Sponsor study identifier
interventional
640
1 country
2
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative delirium (POD) is a common complication in elderly patients undergoing cardiac surgery and is associated with prolonged hospitalization, increased morbidity, and poor recovery. Currently, effective pharmacological strategies for preventing POD remain limited. This study aims to evaluate whether perioperative administration of dezocine can reduce the incidence of postoperative delirium in elderly patients undergoing cardiopulmonary bypass cardiac surgery. This is a prospective, randomized, controlled clinical trial conducted at Fuwai Hospital. Eligible patients aged 65 years or older undergoing elective cardiopulmonary bypass cardiac surgery will be randomly assigned to receive either dezocine or normal saline control in a 1:1 ratio. Patients in the dezocine group will receive intravenous dezocine (0.1 mg/kg) before anesthesia induction and again before transfer out of the operating room. At each administration time point, dezocine will be diluted with normal saline to a total volume of 6 mL and infused intravenously over 3 minutes. Patients in the control group will receive equivalent volumes of normal saline at the corresponding time points. The primary outcome is the incidence of postoperative delirium within 7 days after surgery. Secondary outcomes include delirium characteristics, postoperative recovery outcomes, pain scores, opioid consumption, sedation status, and perioperative complications. This study will investigate the potential role of dezocine as a preventive strategy for postoperative delirium in high-risk elderly cardiac surgery patients.
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January 2028
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August 12, 2026
Actual (reported)August 17, 2026
Actual (reported)September 1, 2026
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December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of postoperative delirium within 7 days after surgery
Within 7 days after surgery
Dezocine will be administered intravenously at a dose of 0.1 mg/kg before anesthesia induction and before transfer out of the operating room. At each administration time point, dezocine will be diluted with 0.9% normal saline to a total volume of 6 mL and infused over 3 minutes.
An equivalent volume of 0.9% normal saline will be administered intravenously at the same time points as the dezocine group, with the same infusion volume and administration procedure.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
First Submitted
August 12, 2026
First Posted
August 17, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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December 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 17, 2026
Record last verified: 2026-08
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