search
Back to results

Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

Primary Purpose

Cognitive Impairment

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Korean version of telephone interview for cognitive status
Sevoflurane
propofol
dexmedetomidine
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cognitive Impairment focused on measuring Geriatrics; Cognitive impairment; Interviews, Telephone

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • diseases of the central nervous system, including dementia (Mini Mental Examination Score <24),
  • consumption of major tranquilizers or antidepressants
  • previous neuropsychological testing
  • the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
  • Parkinson's disease
  • Patients with a severe visual or auditory handicap, illiteracy
  • alcoholism (intake of >5 units of alcohol daily during the last 3 months)
  • drug dependence
  • those not expected to complete the postoperative tests were excluded as well

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    General anesthesia & Control

    Sevoflurane & Propofol & Dexmedetomidine

    Arm Description

    After the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone.

    The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.

    Outcomes

    Primary Outcome Measures

    The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
    Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.

    Secondary Outcome Measures

    The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
    Investigators will assess the postoperative cognitive dysfunction (POCD) after general anesthesia (sevoflurane, propofol and dexmedetomidine) and compare the occurrence rate of the POCD in 3 anesthetic methods.

    Full Information

    First Posted
    October 8, 2014
    Last Updated
    December 1, 2014
    Sponsor
    Pusan National University Yangsan Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02301676
    Brief Title
    Long Term Postoperative Cognitive Dysfunction in the Elderly Patients
    Official Title
    Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Yangsan Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.
    Detailed Description
    In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life. In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history. After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone. Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Impairment
    Keywords
    Geriatrics; Cognitive impairment; Interviews, Telephone

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    General anesthesia & Control
    Arm Type
    Active Comparator
    Arm Description
    After the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone.
    Arm Title
    Sevoflurane & Propofol & Dexmedetomidine
    Arm Type
    Active Comparator
    Arm Description
    The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Korean version of telephone interview for cognitive status
    Other Intervention Name(s)
    TICS
    Intervention Description
    The telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments. Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version. The Korean version of TICS consists of 11 items, total score is 41.
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    sevofrane
    Intervention Description
    Sevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine.
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Other Intervention Name(s)
    fresofol
    Intervention Description
    Propofol is highly protein-bound in vivo and is metabolized by conjugation in the liver. The half-life of elimination of propofol has been estimated to be between 2 and 24 hours.
    Intervention Type
    Device
    Intervention Name(s)
    dexmedetomidine
    Other Intervention Name(s)
    precedex
    Intervention Description
    Dexmedetomidine is a sedative medication used by intensive care units and anesthesiologists. It is relatively unusual in its ability to provide sedation without causing respiratory depression.
    Primary Outcome Measure Information:
    Title
    The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
    Description
    Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
    Description
    Investigators will assess the postoperative cognitive dysfunction (POCD) after general anesthesia (sevoflurane, propofol and dexmedetomidine) and compare the occurrence rate of the POCD in 3 anesthetic methods.
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia Exclusion Criteria: diseases of the central nervous system, including dementia (Mini Mental Examination Score <24), consumption of major tranquilizers or antidepressants previous neuropsychological testing the patient's inability to comply and follow procedures or poor comprehension of the language used in the study. Parkinson's disease Patients with a severe visual or auditory handicap, illiteracy alcoholism (intake of >5 units of alcohol daily during the last 3 months) drug dependence those not expected to complete the postoperative tests were excluded as well
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eun-Jung Kim
    Phone
    821025137881
    Email
    kejdream@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seung-Hoon Baek
    Organizational Affiliation
    Pusan National University Yangsan Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

    We'll reach out to this number within 24 hrs