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Perioperative Dezocine Administration and Postoperative Delirium in Elderly Cardiac Surgery Patients

NCT07768150 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-08-17

No results posted yet for this 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.

Conditions

  • Postoperative Delirium (POD)

Interventions

DRUG

Dezocine

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.

DRUG

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768150 on ClinicalTrials.gov