Perioperative Dezocine Administration and Postoperative Delirium in Elderly Cardiac Surgery Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dezocine

    Drug

    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.

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: Dezocine GroupExperimental treatment 1 intervention
Group B: Normal Saline Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative delirium within 7 days after surgery

Time frame
Within 7 days after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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