Methylprednisolone Combined Electric-acupuncture on Cognitive Function

Postoperative Complication Clinical Trial

Official title:

Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535039
• Other study ID #: Shengjing hospital
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 29, 2015
• Last updated: December 19, 2016
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Shengjing Hospital
• Contact: Yanchao Yang, master
• Phone: 18940252916
• Email: yyc25714104[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged from 65 to 75

• The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class ? ~ 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognitive Retention Disorder
• Memory Disorders
• Postoperative Complication
• Postoperative Complications

Intervention

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

Other:
• Physiological saline
The same volume of physiological saline will be given in Placebo group

Locations

Country	Name	City	State
China	Shengjing hospital of China medical university	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma concentration of IL - 1		Plasma concentration of IL - 1 1 day after the surgey	Yes
Other	Plasma concentration of Aß1-42		Plasma concentration of Aß1-42 1 day after the surgey	Yes
Other	Plasma concentration of p - Tau		Plasma concentration of p - Tau 1 day after the surgey	Yes
Primary	Cognitive function evaluation as measured by Montreal cognitive assessment scale score		Cognitive function evaluation 1 day after the surgey	Yes
Secondary	Plasma concentration of IL - 6		Plasma concentration of IL - 6 1 day after the surgey	Yes