Methylprednisolone Combined Electric-acupuncture on Cognitive Function

NCT ID: NCT02535039

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Complication Cognitive Retention Disorder

Keywords

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Elderly cognitive retention disorder methylprednisolone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Physiological saline

Intervention Type OTHER

The same volume of physiological saline will be given in Placebo group

Methylprednisolne

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.

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

Anaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg \* d for application to the third day after surgery

Interventions

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Methylprednisolone

Anaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg \* d for application to the third day after surgery

Intervention Type DRUG

Physiological saline

The same volume of physiological saline will be given in Placebo group

Intervention Type OTHER

Other Intervention Names

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meprednisone Placebo

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanchao Yang

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junchao Zhu, doctor

Role: STUDY_DIRECTOR

professor

Locations

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Shengjing hospital of China medical university

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanchao Yang, master

Role: CONTACT

Phone: 18940252916

Email: [email protected]

Facility Contacts

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Yanchao Yang, Master

Role: primary

Junchao Zhu, Doctor

Role: backup

Other Identifiers

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Shengjing hospital

Identifier Type: -

Identifier Source: org_study_id