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Not yet recruitingNCT07768150Updated Aug 17, 2026

Perioperative Dezocine Administration and Postoperative Delirium in Elderly Cardiac Surgery Patients

An interventional study of Dezocine and Normal Saline (NS) in Postoperative Delirium (POD), sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Postoperative Delirium (POD)

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Keywords

  • Dezocine
  • Postoperative delirium
  • Cardiopulmonary bypass
  • Cardiac surgery
03

In context

Emergence Delirium

751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's planned enrollment of 640 is above the median of 120 across 464 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age ≥65 years.
  2. Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass.
  3. Ability to complete preoperative cognitive assessment.
  4. Written provided by the patient or legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Severe visual or hearing impairment or other conditions preventing postoperative delirium assessment.
  3. Long-term use of opioid analgesics or sedative-hypnotic medications, or known allergy to dezocine.
  4. Severe hepatic or renal dysfunction.
  5. Emergency surgery, redo sternotomy, aortic surgery, or complex combined cardiac surgery.
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
640 participants (estimated)

Study arms

  • Experimental
    Dezocine Group

    Drug: Dezocine

  • Active comparator
    Normal Saline Control Group

    Drug: Normal Saline (NS)

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative delirium within 7 days after surgery

    Time frame: Within 7 days after surgery

07

Study locations

2 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.

Of 184 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 15 months is below that.

Counting every sponsor, half of 184 studies reached it within 19 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Jan 2028
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07768150
Responsible party
Kexin Liu (Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Aug 17, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Kexin Liu
Contact
kexinliu0212@126.com
+86 15316248964

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dezocine

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