Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 20, 2014
First Posted Date  ICMJE April 25, 2014
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • 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)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery
Official Title  ICMJE The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Ability, General
  • Brain Injury
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Induction of anesthesia
    • Procedure: Intubation
    • Drug: Sevoflurane, remifentanil ,vecuronium
    • Drug: Dexmedetomidine
  • 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.
    Interventions:
    • Drug: Induction of anesthesia
    • Procedure: Intubation
    • Drug: Sevoflurane, remifentanil ,vecuronium
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 24, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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; -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02123355
Other Study ID Numbers  ICMJE SPPHA01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yang Li, Shaanxi Provincial People's Hospital
Study Sponsor  ICMJE Shaanxi Provincial People's Hospital
Collaborators  ICMJE Chinese Medical Association
Investigators  ICMJE Not Provided
PRS Account Shaanxi Provincial People's Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP