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Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

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ClinicalTrials.gov Identifier: NCT02301676
Recruitment Status : Unknown
Verified November 2014 by Eun-Jung Kim, Pusan National University Yangsan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Eun-Jung Kim, Pusan National University Yangsan Hospital

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Behavioral: Korean version of telephone interview for cognitive status Drug: Sevoflurane Drug: propofol Device: dexmedetomidine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: General anesthesia & Control
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.
Behavioral: Korean version of telephone interview for cognitive status
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.
Other Name: TICS

Active Comparator: Sevoflurane & Propofol & Dexmedetomidine
The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.
Drug: Sevoflurane
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.
Other Name: sevofrane

Drug: propofol
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.
Other Name: fresofol

Device: dexmedetomidine
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.
Other Name: precedex




Primary Outcome Measures :
  1. The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients. [ Time Frame: two years ]
    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 :
  1. The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs [ Time Frame: two years ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301676


Contacts
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Contact: Eun-Jung Kim 821025137881 kejdream@gmail.com

Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Study Chair: Seung-Hoon Baek Pusan National University Yangsan Hospital

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Responsible Party: Eun-Jung Kim, anesthesiologist, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT02301676     History of Changes
Other Study ID Numbers: LPOCD60
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Eun-Jung Kim, Pusan National University Yangsan Hospital:
Geriatrics; Cognitive impairment; Interviews, Telephone

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Platelet Aggregation Inhibitors
Anesthetics, Inhalation