Dexmedetomidine and Delirium in Patients After Cardiac Surgery

NCT02267538 | Completed Phase 4 Results DMC

• 1 other identifier: PekingUFH
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Delirium; Cardiac Surgical Procedures; Postoperative Complications; Dexmedetomidine; Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery.

  During the first five days after surgery

Secondary Outcomes (2)

• Cognitive Function

  on the sixth day after surgery, and on the 30th day after surgery

• Incidence of Non-delirium Complications After Surgery

  Occurrence of non-delirium complications will be monitored until 30 days after surgery.

Other Outcomes (4)

• Pain Intensity

  During the first five days after surgery

• Subjective Sleep Quality

  During the first five days after surgery

• Length of Stay in the Intensive Care Unit

  From end of surgery until discharge from Intensive Care Unit or 30 days after surgery

Study Arms (2)

Dex group

EXPERIMENTAL

The intervention drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.

Drug: dexmedetomidine hydrochloride for injection

Placebo group

PLACEBO COMPARATOR

The placebo drug (normal saline, i.e., 0.9% sodium chloride for injection) will be administered in the same way and rate for a same duration as that in the Dex group.

Drug: 0.9% sodium chloride for injection

Interventions

dexmedetomidine hydrochloride for injection DRUG

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.

Also known as: Aibeining (trade name)

Dex group

0.9% sodium chloride for injection DRUG

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.

Also known as: normal saline

Placebo group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery)

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Refuse to participate;
• Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
• Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
• History of brain injury or neurosurgery;
• Preoperative sick sinus syndrome, severe bradycardia (HR \< 50 bpm), second-degree or above atrioventricular block without pacemaker;
• Severe hepatic dysfunction (Child-Pugh class C);
• Severe renal dysfunction (requirement of renal replacement therapy);
• Other conditions that are considered unsuitable for participation.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (49)

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Related Links

• Different versions of Confusion Assessemnt Method for the Intensive Care Unit (CAM-ICU) and their validation papers were found in this web.

MeSH Terms

Conditions

Delirium; Postoperative Complications

Interventions

Dexmedetomidine; Injections; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Dong-Xin Wang,PHD,the director of department of Anesthesiology and Critical Care Medicine
• Organization: Peking University First Hospital

wangdongxin@hotmail.com

+8613910731903

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 17, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)