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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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
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
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
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301676
|Contact: Eun-Jung Kimfirstname.lastname@example.org|
|Study Chair:||Seung-Hoon Baek||Pusan National University Yangsan Hospital|