Long Term Postoperative Cognitive Dysfunction in the Elderly Patients

NCT02301676 | Unknown Phase 4

• 1 other identifier: LPOCD60
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Impairment

Keywords

Geriatrics; Cognitive impairment; Interviews, Telephone

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Secondary Outcomes (1)

• The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs

  two years

Study Arms (2)

General anesthesia & Control

ACTIVE COMPARATOR

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

Sevoflurane & Propofol & Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Sevoflurane; Drug: propofol; Device: dexmedetomidine

Interventions

Korean version of telephone interview for cognitive status BEHAVIORAL

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.

Also known as: TICS

General anesthesia & Control

Sevoflurane DRUG

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.

Also known as: sevofrane

Sevoflurane & Propofol & Dexmedetomidine

propofol DRUG

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.

Also known as: fresofol

Sevoflurane & Propofol & Dexmedetomidine

dexmedetomidine DEVICE

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.

Also known as: precedex

Sevoflurane & Propofol & Dexmedetomidine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Seung-Hoon Baek

  Pusan National University Yangsan Hospital

  STUDY CHAIR

Central Study Contacts

Eun-Jung Kim

CONTACT

821025137881; kejdream@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 2, 2014

Record last verified: 2014-11