Postoperative Delirium (POD)NCT07768150
Perioperative Dezocine Administration and Postoperative Delirium in Elderly Cardiac Surgery Patients
A study testing Dezocine and Normal Saline (NS) in people with Postoperative Delirium (POD), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Dezocine and Normal Saline (NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2026to Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years.
- Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
- Ability to complete preoperative cognitive assessment.
- Written informed consent provided by the patient or legally authorized representative.
Who cannot join
- Pre-existing neurological or psychiatric disorders that may affect postoperative delirium assessment, including dementia, active delirium, severe psychiatric disorders, recent stroke, or other severe neurological diseases.
- Severe visual or hearing impairment or other conditions preventing postoperative delirium assessment.
- Long-term use of opioid analgesics or sedative-hypnotic medications, or known allergy to dezocine.
- Severe hepatic or renal dysfunction.
- Emergency surgery, redo sternotomy, aortic surgery, or complex combined cardiac surgery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Kexin Liu, +86 15316248964, kexinliu0212@126.com
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: Effect of Perioperative Dezocine Administration on Postoperative Delirium in Elderly Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Dezocine, Normal Saline (NS)
- Keywords
- Dezocine, Postoperative delirium, Cardiopulmonary bypass, Cardiac surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DezocineDrug
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.
Normal Saline (NS)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dezocine Group | Experimental | Not described Receives: Drug: Dezocine |
| Normal Saline Control Group | Active comparator | Not described Receives: Drug: Normal Saline (NS) |
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
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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, Care provider
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kexin Liu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768150
- Sponsor's protocol ID
- FW-DEZ-POD-2026
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Dezocine Administration on Postoperative Delirium in Elderly Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07768150
- Acronym / sponsor ID
- FW-DEZ-POD-2026
- Conditions
- Postoperative Delirium (POD)
- Keywords
- Dezocine, Postoperative delirium, Cardiopulmonary bypass, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Aug 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dezocine Group | Experimental | Drug: Dezocine |
| Normal Saline Control Group | Active comparator | Drug: Normal Saline (NS) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years.
- Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
- Ability to complete preoperative cognitive assessment.
- Written informed consent provided by the patient or legally authorized representative.
Key exclusion criteria (5 listed)
- Pre-existing neurological or psychiatric disorders that may affect postoperative delirium assessment, including dementia, active delirium, severe psychiatric disorders, recent stroke, or other severe neurological diseases.
- Severe visual or hearing impairment or other conditions preventing postoperative delirium assessment.
- Long-term use of opioid analgesics or sedative-hypnotic medications, or known allergy to dezocine.
- Severe hepatic or renal dysfunction.
- Emergency surgery, redo sternotomy, aortic surgery, or complex combined cardiac surgery.
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 |
|---|---|---|
| DezocineDezocine 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. | Drug | Dezocine Group |
| Normal Saline (NS)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. | Drug | Normal Saline Control Group |
Primary outcome
Incidence of postoperative delirium within 7 days after surgery
Time frame: Within 7 days after surgery
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 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium (POD)
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dezocine and Normal Saline (NS) in people with Postoperative Delirium (POD), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Kexin Liu (+86 15316248964, kexinliu0212@126.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: Within 7 days after surgery). 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 17 Aug 2026.