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NCT Number: NCT02275182

Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.

Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.

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Key information

Conditions

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

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anqing Municipal Hospital, Anqing, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
  • Age 65-90 yrs；
  • Anesthesia Society of American (ASA) Scale II~III；
  • Anticipated surgery time 2-6 hrs； -

Exclusion criteria

  • Dementia patients（Mini-mental state examination< 20）
  • Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
  • Unstable metal status and mental disease；
  • The cognitive function examination in 3-6 months is not anticipated to be completed
  • II-III Atrioventricular block；
  • Heat rate < 50 beats/minutes；
  • Parkinson's Disease；
  • May occur or have occurred the difficult airway or anticipated delayed extubation
  • Sure or suspected abuse of analgesic and sedation drug；
  • Allergic to the trial drug and other anesthesia drug contraindication； -

Treatment and study plan

Dexmedetomidine

Drug

0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.

Other names: Yisi

Saline

Drug

0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.

Primary outcomes

  1. The change of incidence of postoperative cognition dysfunction

    Time frame: 1 day Before surgery,the 3rd,7th day after the surgery.

    • The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively.
    • A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min.
    • Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference.
    • Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation（SD）of the difference of the normal population, that is ΔX / SD and it is the Z score.
    • POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.

  2. The change of incidence of postoperative delirium

    Time frame: The first, second and third day after the surgery.

    Through CAM-ICU to assess the incidence of the postoperative delirium.

  3. The change of Neuropsychological status

    Time frame: the 3rd,6th month after the surgery

    Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.

Secondary outcomes

  1. The occurrence of cardiovascular events.

    Time frame: from begging of the anesthesia to the time the patients discharge, up to 1 month.

  2. The incidence of any adverse or severe adverse events.

    Time frame: From the beginning of the admitted to 6 month after the surgery, up to 6 month.

    Including kidney or brain related adverse events.

  3. The variation of heart rate.

    Time frame: From the beginning to the end of anesthesia,up to 6 hours.

    Heart rate is recorded every 15 minutes during the anesthesia.

  4. The variation of blood pressure.

    Time frame: From the beginning to the end of anesthesia,up to 6 hours.

    blood pressure is recorded every 15 minutes during the anesthesia.

  5. the variation of pulse oxygen saturation.

    Time frame: From the beginning to the end of anesthesia,up to 6 hours.

    Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.

  6. The monitor of depth of anesthesia.

    Time frame: From the beginning to the end of anesthesia,up to 6 hours.

    Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.

  7. The serum concentrations of BDNF

    Time frame: From the baseline to the 3-day,7-day and 1-month.

    Serum level of brain-derived neurotrophic factor (BDNF) was measured

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2014
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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