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Methylprednisolone Combined Electric-acupuncture on Cognitive Function

Primary Purpose

Postoperative Complication, Cognitive Retention Disorder

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone
Physiological saline
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complication focused on measuring Elderly, cognitive retention disorder, methylprednisolone

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged from 65 to 75
  • The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ ~ III
  • With a primary culture of above (including elementary school)
  • There is no history of drug allergy.

Exclusion Criteria:

  • Central nervous system and history of mental illness
  • Taking sedatives or antidepressants history
  • Insulin dependent diabetes
  • Coronary heart disease
  • Cerebral infarction
  • Preoperative MOCA score less than 26 points

Sites / Locations

  • Shengjing hospital of China medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Methylprednisolne

Arm Description

Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.The same volume of physiological saline will be given.

in the anaesthesia to 1 mg/kg intravenous methylprednisolone, methylprednisolone continuous use 1 mg/kg * d until the third day after surgery.Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.

Outcomes

Primary Outcome Measures

Cognitive function evaluation as measured by Montreal cognitive assessment scale score

Secondary Outcome Measures

Plasma concentration of IL - 6

Full Information

First Posted
May 29, 2015
Last Updated
December 19, 2016
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02535039
Brief Title
Methylprednisolone Combined Electric-acupuncture on Cognitive Function
Official Title
Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (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
Shengjing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative cognitive dysfunction (POCD) refers to the patients in the central nervous system complications after general anesthesia and clinical manifestations of mental disorder, anxiety, personality changes, impaired memory, personality, social skills and cognitive function after surgery for this decline is called postoperative cognitive dysfunction.Due to the lack of effective clinical treatments, how to prevent and solve the postoperative cognitive dysfunction has become a difficulty and a focus of research in the field of anesthesia.Methylprednisolone is a new type of cortical hormone, because of its strong anti-inflammatory effect, less adverse reactions, is widely used in clinical anesthesia.Electric acupuncture as a kind of traditional treatments, after years of clinical application and achieved good curative effect in practice.In this paper by comparing brain oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function. Through comparing the operation of cerebral oxygen saturation, blood biochemical indexes, Montreal cognitive assessment scale (MOCA) on cognitive function in patients with grade indexes, such as observation of methylprednisolone combined electric acupuncture treatment of elderly patients with general anesthesia early after the operation, the influence of cognitive function.
Detailed Description
Choose descending colon cancer radical general anesthesia, 80 cases of patients, ASA Ⅱ ~ level III, aged 65 ~ 75, were randomly divided into two groups: anesthesia method selects the tracheal intubation general anesthesia.All Diprifusor propofol used in patients with TCI system, with the initial plasma concentration of 2.0 ug/ml start TCI, and intravenous sufentanil injection 0.15 ug/kg, propofol 1 ug/ml every 1 minute.After the BIS value < 75, start the fentanyl TCI system, maintaining the plasma concentrations of 4 ng/ml, vein to the interaction between rocuronium 0.8 mg/kg, insert the endotracheal intubation after mechanical ventilation.Adjust the propofol infusion control electrical double-frequency index between 45 to 55.The experimental group to give intravenous methylprednisolone 1 mg/kg/sack.And 1 mg/kg * d continuous application to the third day after surgery. 1 day before the surgery, postoperative 1 day, 2 days, 3 days, 7 days the MOCA scale to assess cognitive function after surgery for the patient.(T0) prior to the induction and bi (T1), 24 h after surgery (T2) and 48 h after surgery (T3) extraction in patients with venous blood, adopts the method of enzyme-linked immunosorbent (ELISA) determination of serum IL - 1 beta, IL - 6, Aβ1-42, p- Tau concentration.In rSO2 intraoperative continuous monitoring, and calculate the average rSO2, intraoperative rSO2 down the biggest percentage compared with basic value rSO2 % of Max.And record the occurrence of adverse reactions to special circumstances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complication, Cognitive Retention Disorder
Keywords
Elderly, cognitive retention disorder, methylprednisolone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.The same volume of physiological saline will be given.
Arm Title
Methylprednisolne
Arm Type
Experimental
Arm Description
in the anaesthesia to 1 mg/kg intravenous methylprednisolone, methylprednisolone continuous use 1 mg/kg * d until the third day after surgery.Before anesthesia induction, with electroacupuncture can cave, inside the closed cavity, foot three mile point, cupping model for continuous wave type, current pulse frequency of 2 hz, adjust the intensity of the electric acupuncture, with patients complained of needle feeling, can accept no pain and discomfort.Intraoperative sustained electroacupuncture.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
meprednisone
Intervention Description
Anaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg * d for application to the third day after surgery
Intervention Type
Other
Intervention Name(s)
Physiological saline
Other Intervention Name(s)
Placebo
Intervention Description
The same volume of physiological saline will be given in Placebo group
Primary Outcome Measure Information:
Title
Cognitive function evaluation as measured by Montreal cognitive assessment scale score
Time Frame
Cognitive function evaluation 1 day after the surgey
Secondary Outcome Measure Information:
Title
Plasma concentration of IL - 6
Time Frame
Plasma concentration of IL - 6 1 day after the surgey
Other Pre-specified Outcome Measures:
Title
Plasma concentration of IL - 1
Time Frame
Plasma concentration of IL - 1 1 day after the surgey
Title
Plasma concentration of Aβ1-42
Time Frame
Plasma concentration of Aβ1-42 1 day after the surgey
Title
Plasma concentration of p - Tau
Time Frame
Plasma concentration of p - Tau 1 day after the surgey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged from 65 to 75 The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ ~ III With a primary culture of above (including elementary school) There is no history of drug allergy. Exclusion Criteria: Central nervous system and history of mental illness Taking sedatives or antidepressants history Insulin dependent diabetes Coronary heart disease Cerebral infarction Preoperative MOCA score less than 26 points
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanchao Yang, master
Phone
18940252916
Email
yyc25714104@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu, doctor
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing hospital of China medical university
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanchao Yang, Master
Phone
18940252916
Email
yyc25714104@163.com
First Name & Middle Initial & Last Name & Degree
Junchao Zhu, Doctor
Phone
18940257257
Email
zhujunchao1@hotmail.com

12. IPD Sharing Statement

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