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Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Primary Purpose

Postoperative Confusion, Delirium

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Saline
Sponsored by
The First Affiliated Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Confusion focused on measuring Dexmedetomidine

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent
  2. Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred);
  3. Age 65-90 yrs;
  4. Anesthesia Society of American (ASA) Scale II~III;
  5. Anticipated surgery time 2-6 hrs; -

Exclusion Criteria:

  1. Dementia patients(Mini-mental state examination< 20)
  2. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction;
  3. Unstable metal status and mental disease;
  4. The cognitive function examination in 3-6 months is not anticipated to be completed
  5. II-III Atrioventricular block;
  6. Heat rate < 50 beats/minutes;
  7. Parkinson's Disease;
  8. May occur or have occurred the difficult airway or anticipated delayed extubation
  9. Sure or suspected abuse of analgesic and sedation drug;
  10. Allergic to the trial drug and other anesthesia drug contraindication; -

Sites / Locations

  • Anqing Municipal Hospital
  • Affiliated Hospital of Bengbu Medical College
  • Affiliated Chaohu Hospital of Anhui Medical Hospital
  • Binhu Hospital of Hefei
  • Second Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Anhui Medical University
  • The first Hospital of Hefei
  • The Second Hospital of Hefei
  • The Second People's Hospital of Anhui
  • the people's Hospital of Liuan
  • the people's Hospital of Tongling
  • The First Affiliated Hospital of Wannan Medical College
  • The second People's Hospital of Wuhu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Controlled

Arm Description

0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.

0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.

Outcomes

Primary Outcome Measures

The change of incidence of postoperative cognition dysfunction
The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively. A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min. Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference. Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation(SD)of the difference of the normal population, that is ΔX / SD and it is the Z score. POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.
The change of incidence of postoperative delirium
Through CAM-ICU to assess the incidence of the postoperative delirium.
The change of Neuropsychological status
Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.

Secondary Outcome Measures

The occurrence of cardiovascular events.
The incidence of any adverse or severe adverse events.
Including kidney or brain related adverse events.
The variation of heart rate.
Heart rate is recorded every 15 minutes during the anesthesia.
The variation of blood pressure.
blood pressure is recorded every 15 minutes during the anesthesia.
the variation of pulse oxygen saturation.
Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.
The monitor of depth of anesthesia.
Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.
The serum concentrations of BDNF
Serum level of brain-derived neurotrophic factor (BDNF) was measured

Full Information

First Posted
October 21, 2014
Last Updated
April 23, 2018
Sponsor
The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02275182
Brief Title
Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients
Official Title
Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Anhui Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test. Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Confusion, Delirium
Keywords
Dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
864 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.
Arm Title
Controlled
Arm Type
Placebo Comparator
Arm Description
0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Yisi
Intervention Description
0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
Primary Outcome Measure Information:
Title
The change of incidence of postoperative cognition dysfunction
Description
The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively. A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min. Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference. Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation(SD)of the difference of the normal population, that is ΔX / SD and it is the Z score. POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.
Time Frame
1 day Before surgery,the 3rd,7th day after the surgery.
Title
The change of incidence of postoperative delirium
Description
Through CAM-ICU to assess the incidence of the postoperative delirium.
Time Frame
The first, second and third day after the surgery.
Title
The change of Neuropsychological status
Description
Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.
Time Frame
the 3rd,6th month after the surgery
Secondary Outcome Measure Information:
Title
The occurrence of cardiovascular events.
Time Frame
from begging of the anesthesia to the time the patients discharge, up to 1 month.
Title
The incidence of any adverse or severe adverse events.
Description
Including kidney or brain related adverse events.
Time Frame
From the beginning of the admitted to 6 month after the surgery, up to 6 month.
Title
The variation of heart rate.
Description
Heart rate is recorded every 15 minutes during the anesthesia.
Time Frame
From the beginning to the end of anesthesia,up to 6 hours.
Title
The variation of blood pressure.
Description
blood pressure is recorded every 15 minutes during the anesthesia.
Time Frame
From the beginning to the end of anesthesia,up to 6 hours.
Title
the variation of pulse oxygen saturation.
Description
Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.
Time Frame
From the beginning to the end of anesthesia,up to 6 hours.
Title
The monitor of depth of anesthesia.
Description
Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.
Time Frame
From the beginning to the end of anesthesia,up to 6 hours.
Title
The serum concentrations of BDNF
Description
Serum level of brain-derived neurotrophic factor (BDNF) was measured
Time Frame
From the baseline to the 3-day,7-day and 1-month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred); Age 65-90 yrs; Anesthesia Society of American (ASA) Scale II~III; Anticipated surgery time 2-6 hrs; - Exclusion Criteria: Dementia patients(Mini-mental state examination< 20) Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction; Unstable metal status and mental disease; The cognitive function examination in 3-6 months is not anticipated to be completed II-III Atrioventricular block; Heat rate < 50 beats/minutes; Parkinson's Disease; May occur or have occurred the difficult airway or anticipated delayed extubation Sure or suspected abuse of analgesic and sedation drug; Allergic to the trial drug and other anesthesia drug contraindication; -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Er Gu
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anqing Municipal Hospital
City
Anqing
State/Province
Anhui
Country
China
Facility Name
Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Affiliated Chaohu Hospital of Anhui Medical Hospital
City
Chaohu
State/Province
Anhui
Country
China
Facility Name
Binhu Hospital of Hefei
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The first Hospital of Hefei
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The Second Hospital of Hefei
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The Second People's Hospital of Anhui
City
Hefei
State/Province
Anhui
Country
China
Facility Name
the people's Hospital of Liuan
City
Liuan
State/Province
Anhui
Country
China
Facility Name
the people's Hospital of Tongling
City
Tongling
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Facility Name
The second People's Hospital of Wuhu
City
Wuhu
State/Province
Anhui
Country
China

12. IPD Sharing Statement

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Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

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