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Dexmedetomidine and Long-term Outcome in Elderly Patients After Surgery

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ClinicalTrials.gov Identifier: NCT02809937
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
Peking University Third Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Aged Surgical Procedures, Operative Delirium Dexmedetomidine Mortality Long-term Survivors Drug: dexmedetomidine Drug: placebo Phase 4

Detailed Description:

Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.

In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo [normal saline] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1% [32/350] with dexmedetomidine; Odds Ratio 0.35, 95% Confidence Interval 0.22 to 0.54; p < 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.

The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 3-year Follow-up of a Randomized Controlled Trial
Actual Study Start Date : May 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine group
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
low-dose dexmedetomidine infusion
Other Name: dexmedetomidine hydrochloride

Placebo Comparator: placebo group
Normal saline was infused in the same rate for the same duration as that in the placebo group.
Drug: placebo
normal saline infusion
Other Name: normal saline or 0.9% sodium chloride




Primary Outcome Measures :
  1. Duration of survival after surgery [ Time Frame: From the day of surgery until the end of the 3rd year after surgery ]
    Duration of survival after surgery


Secondary Outcome Measures :
  1. Survival rates after surgery [ Time Frame: At 6 months, 1 year, 2 years and 3 years after surgery ]
    Survival rates at different timepoints after surgery

  2. Cognitive function in 3-year survivors after surgery [ Time Frame: At the end of the 3rd year after surgery ]
    Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).

  3. Health related quality of life in 3-year survivors after surgery [ Time Frame: At the end of the 3rd year after surgery ]
    Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).


Other Outcome Measures:
  1. Survival rates in the subgroup of patients after cancer or non-cancer surgery [ Time Frame: At 6 months, 1 year, 2 years and 3 years after surgery ]
    Survival rates at different timepoints in the subgroup of patients after cancer or non-cancer surgery

  2. Duration of survival in the subgroup of patients after cancer or non-cancer surgery [ Time Frame: From the day of surgery until the end of the 3rd year after surgery ]
    Duration of survival in the subgroup of patients after cancer or non-cancer surgery

  3. Cognitive function in the subgroup of 3-year survivors after cancer or non-cancer surgery [ Time Frame: At the end of the 3rd year after surgery ]
    Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).

  4. Health related quality of life in the subgroup of 3-year survivors after cancer or non-cancer surgery [ Time Frame: At the end of the 3rd year after surgery ]
    Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients were included if they met all of the following criteria:

  1. Age of 65 years or older;
  2. Underwent elective noncardiac surgery under general anesthesia;
  3. Admitted to ICU after surgery.

Exclusion Criteria:

Patients were excluded if they met any of the following criteria:

  1. Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
  2. Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
  3. Brain injury or neurosurgery;
  4. 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;
  5. Serious hepatic dysfunction (Child-Pugh class C);
  6. Serious renal dysfunction (undergoing dialysis before surgery); or
  7. Unlikely to survive for more than 24 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809937


Locations
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China, Beijing
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Peking University Third Hospital
Investigators
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Principal Investigator: Dong-Xin Wang, MD,PhD Peking University First Hospital

Publications:
[28] Jorden VSB, et al. Dexmedetomidine: clinical update. Semin Anesth Periop Med Pain 2002;21:265-74.

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Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02809937    
Other Study ID Numbers: 2014[711]
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
aged
surgical procedures, operative
delirium
dexmedetomidine
long-term outcome
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action