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The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

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ClinicalTrials.gov Identifier: NCT02123355
Recruitment Status : Unknown
Verified April 2014 by Yang Li, Shaanxi Provincial People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by (Responsible Party):
Yang Li, Shaanxi Provincial People's Hospital

Brief Summary:

The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.

Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.

The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.


Condition or disease Intervention/treatment Phase
Cognitive Ability, General Brain Injury Drug: Induction of anesthesia Procedure: Intubation Drug: Sevoflurane, remifentanil ,vecuronium Drug: Dexmedetomidine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
Study Start Date : August 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Drug: Induction of anesthesia
Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection

Procedure: Intubation
After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35~40 mmHg,pulse oxygen saturation is more than 95%.

Drug: Sevoflurane, remifentanil ,vecuronium
Sevoflurane(1%-2%)is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.

Drug: Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Sham Comparator: Normal saline
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Drug: Induction of anesthesia
Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection

Procedure: Intubation
After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35~40 mmHg,pulse oxygen saturation is more than 95%.

Drug: Sevoflurane, remifentanil ,vecuronium
Sevoflurane(1%-2%)is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.

Drug: Placebo
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.




Primary Outcome Measures :
  1. Change from baseline in cognitive function at 7 days [ Time Frame: Baseline, the 7th day after the surgery ]
    1. Modified Newman scale to assess the cognitive function, including five tests.
    2. The quiet environment, enough daylight, no disturb is needed when the modified Newman scale is done. All the five tests are finished within 30 min.
    3. all the score of each test of all the patients assessed before the surgery is calculated, then get the standard variation, the score of each subject of each test is compared with the standard deviation, if one or more stand deviation decrease, then the cognitive function is considered as deterioration .
    4. When 2 or more of the tests is considered as deterioration, then the patients is diagnosed as Post Operation Cognitive Dysfunction (POCD).


Secondary Outcome Measures :
  1. Brain injury assessment [ Time Frame: From entering the operating room to 48 hours after the surgery ]
    1. 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.
    2. The serum level of C-reaction protein(CRP),tumor necrosis factor(TNF-α)、interleukin-6(IL-6),interleukin-10(IL-10) is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA)

  2. Inflammatory responsive assessment [ Time Frame: From entering the operating room to 48 hours after the surgery ]
    1. 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.
    2. The concentration of protein S100B(S100B)and neuron specific enolase (NSE)in serum is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA).

  3. Heart rate [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

  4. Depth of anesthesia [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Bispectral index(BIS) monitor are performed every 15 min from the induction of anesthesia to the right moment of extubation.

  5. Recovery of anesthesia [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Time of anesthetic ceased,time of call to open eyes,time to extubation, time to leave the PACU are recorded.

  6. Central venous pressure(CVP) [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Central venous pressure(CVP) are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

  7. Blood pressure [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    systolic blood pressure, Diastolic blood pressure are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

  8. Respiration rate [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Respiration rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

  9. Pulse blood oxygen saturation [ Time Frame: From the induction of anesthesia to the right moment of extubation, up to 1 day. ]
    Pulse blood oxygen saturation are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

  10. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 7 days ]


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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:

  1. Written informed consent
  2. Scheduled for elective abdominal surgery
  3. Age≥65 yrs
  4. Weight is within the range of ±20% of standard weight [standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪] for female
  5. American society of anesthesia classification I~III
  6. Expected time of surgery is more than 4 hours -

Exclusion Criteria:

  1. Systolic blood pressure≥180 mm Hg or <90 mm Hg,diastolic blood pressure≥110 mm Hg or < 60 mm Hg;
  2. Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
  3. Allergy to trial drug or other contraindication;
  4. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
  5. History of mental illness and cerebral vascular disease
  6. History of unstable angina or myocardial infarction
  7. Education level<7 yrs
  8. Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.
  9. Abuse of narcotic analgesia or suspected;
  10. Neuromuscular diseases;
  11. Mentally unstable or has a mental illness;
  12. Pregnant or breast-feeding women;
  13. Attended other trial past 30 days; -

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Responsible Party: Yang Li, Anesthesiologist, Shaanxi Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02123355     History of Changes
Other Study ID Numbers: SPPHA01
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Dexmedetomidine
Remifentanil
Sevoflurane
Vecuronium Bromide
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
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
Analgesics, Opioid
Narcotics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General