Dexmedetomidine and Long-term Outcome in Elderly Patients After Surgery

NCT02809937 | Completed Phase 4 DMC

• 1 other identifier: 2014[711]
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.

Conditions

Aged; Surgical Procedures, Operative; Delirium; Dexmedetomidine; Mortality; Long-term Survivors

Keywords

aged; surgical procedures, operative; delirium; dexmedetomidine; long-term outcome

Outcome Measures

Primary Outcomes (1)

• Duration of survival after surgery

  Duration of survival after surgery

  From the day of surgery until the end of the 3rd year after surgery

Secondary Outcomes (3)

• Survival rates after surgery

  At 6 months, 1 year, 2 years and 3 years after surgery

• Cognitive function in 3-year survivors after surgery

  At the end of the 3rd year after surgery

• Health related quality of life in 3-year survivors after surgery

  At the end of the 3rd year after surgery

Other Outcomes (4)

• Survival rates in the subgroup of patients after cancer or non-cancer surgery

  At 6 months, 1 year, 2 years and 3 years after surgery

• Duration of survival in the subgroup of patients after cancer or non-cancer surgery

  From the day of surgery until the end of the 3rd year after surgery

• Cognitive function in the subgroup of 3-year survivors after cancer or non-cancer surgery

  At the end of the 3rd year after surgery

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

For patients who were not intubated, dexmedetomidine was infused at a rate of 0.1 microgram/kg per hour from study recruitment on the day of surgery until 8:00 am on the first day after surgery. For patients who were intubated and mechanically ventilated, dexmedetomidine infusion was started after the Richmond Agitation Sedation Scale was -2 or higher after intensive care unit admission until 8:00 am on the first day after surgery.

Drug: dexmedetomidine

placebo group

PLACEBO COMPARATOR

Normal saline was infused in the same rate for the same duration as that in the placebo group.

Drug: placebo

Interventions

dexmedetomidine DRUG

low-dose dexmedetomidine infusion

Also known as: dexmedetomidine hydrochloride

dexmedetomidine group

placebo DRUG

normal saline infusion

Also known as: normal saline or 0.9% sodium chloride

placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients were included if they met all of the following criteria:
• Age of 65 years or older;
• Underwent elective noncardiac surgery under general anesthesia;
• Admitted to ICU after surgery.

You may not qualify if:

• Patients were excluded if they met any of the following criteria:
• Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
• Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
• Brain injury or neurosurgery;
• Preoperative left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker;
• Serious hepatic dysfunction (Child-Pugh class C);
• Serious renal dysfunction (undergoing dialysis before surgery); or
• Unlikely to survive for more than 24 hours.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

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 and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: May 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)