Methylprednisolone Combined Electric-acupuncture on Cognitive Function

NCT02535039 | Unknown Phase 1 DMC

• 1 other identifier: Shengjing hospital
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complication; Cognitive Retention Disorder

Keywords

Elderly; cognitive retention disorder; methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Cognitive function evaluation as measured by Montreal cognitive assessment scale score

  Cognitive function evaluation 1 day after the surgey

Secondary Outcomes (1)

• Plasma concentration of IL - 6

  Plasma concentration of IL - 6 1 day after the surgey

Other Outcomes (3)

• Plasma concentration of IL - 1

  Plasma concentration of IL - 1 1 day after the surgey

• Plasma concentration of Aβ1-42

  Plasma concentration of Aβ1-42 1 day after the surgey

• Plasma concentration of p - Tau

  Plasma concentration of p - Tau 1 day after the surgey

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Other: Physiological saline

Methylprednisolne

EXPERIMENTAL

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.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

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

Also known as: meprednisone

Methylprednisolne

Physiological saline OTHER

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Memory Disorders

Interventions

Methylprednisolone; meprednisone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Junchao Zhu, doctor

  professor

  STUDY DIRECTOR

Central Study Contacts

Yanchao Yang, master

CONTACT

18940252916; yyc25714104@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: August 28, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

CN (1)