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Dexmedetomidine and Delirium in Patients After Cardiac Surgery

NCT02267538 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2018-03-05

Study results available
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Summary

Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.

Conditions

  • Delirium
  • C.Surgical Procedure; Cardiac
  • Postoperative Complications

Interventions

DRUG

dexmedetomidine hydrochloride for injection

Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml). Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 μg/kg in 10 minutes), followed by continuous infusion at a rate of \[0.1\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.4 μg /kg/h) until the end of surgery. At the end of surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation after surgery.

DRUG

0.9% sodium chloride for injection

Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared. Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of \[0.9\*kg\] ml/h for 10 minutes, followed by continuous infusion at a rate of \[0.1\*kg\] ml/h until the end of surgery. At the end of surgery, the infusion rate will be decreased to \[0.025\*kg\] ml/h and continued until the end of mechanical ventilation after surgery.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-08-31
Completion
2015-11-30

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 NCT02267538 on ClinicalTrials.gov