POCD;TCI: The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index

Sponsor
Guangzhou General Hospital of Guangzhou Military Command (Other)
Overall Status
Unknown status
CT.gov ID
NCT03010098
Collaborator
(none)
60
1
2
5.9
10.1

Study Details

Study Description

Brief Summary

To investigate the effect on older's cognition of the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .

Condition or Disease Intervention/Treatment Phase
  • Device: Dual-Loop TCI
  • Device: Open-Loop TCI
Phase 4

Detailed Description

Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.Taking an exam of MMSE before and after the surgery which measures if the older's cognition changed. Furthermore.we will measure the levels of protein S100beta and NSE.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dual-Loop TCI

the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.

Device: Dual-Loop TCI
the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46
Other Names:
  • Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Inde
  • Experimental: Open-Loop TCI

    the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.

    Device: Open-Loop TCI
    the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
    Other Names:
  • Control infusion of propofol and remifentanil guided by experience
  • Outcome Measures

    Primary Outcome Measures

    1. MMSE scores [up to 1 week]

      The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.We measure the patient before the operation and the first/third/seventh day after the operation.

    Secondary Outcome Measures

    1. protein s100beta [up to 24 hours]

      The calcium-binding protein S100b is enriched in astroglial cells and can cross the blood-brain barrier after hypoxic damage of the central nervous system. Its routine measurement is simple and relatively inexpensive. S100b is filtrated by the kidney and has an estimated half-life of 2 h . Its serum level increases after CA, and its prognostic value has been studied . Because of mitigated results, its routine use has been, up to now, not recommended. S100bata is normally 0.2μg/L in serum or more smaller.We decide to take the blood sample before the operation and after the operation when the patient is awake.

    Other Outcome Measures

    1. NSE [up to 24 hours]

      NSE has a role in glucose metabolism. As for S100b, NSE is released from the hypoxic brain into the bloodstream, and its serum level correlates with the extent of brain injury. Also, NSE correlates with other markers of brain injury . NSE has a high specificity to predict adverse outcomes when measured in the few days post CA. A cutoff point of 33 mg/l is recommended.in our study, we take the blood sample before the operation and after the operation when the patient awake.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.

    2. Written informed consent from the patient or the relatives of the participating patient.

    3. BMI:18.0~25 kg/m2

    Exclusion Criteria:
    1. Mental illness can not match

    2. epidural anesthesia contraindicated

    3. People who have Slow-type arrhythmias

    4. Chronic renal failure

    5. Alcohol or drug abuse

    6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Military Region General Hospital, Department of Anesthesiology Guangzhou Guangdong China 510010

    Sponsors and Collaborators

    • Guangzhou General Hospital of Guangzhou Military Command

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
    ClinicalTrials.gov Identifier:
    NCT03010098
    Other Study ID Numbers:
    • double closed-loop and POCD
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2017