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Methylprednisolone Combined Electric-acupuncture on Cognitive Function

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02535039
Enrollment
80
Registered
2015-08-28
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Retention Disorder, Postoperative Complication

Keywords

Elderly, cognitive retention disorder, methylprednisolone

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.

Interventions

DRUGMethylprednisolone

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

OTHERPhysiological saline

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

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Cognitive function evaluation as measured by Montreal cognitive assessment scale scoreCognitive function evaluation 1 day after the surgey

Secondary

MeasureTime frame
Plasma concentration of IL - 6Plasma concentration of IL - 6 1 day after the surgey

Other

MeasureTime frame
Plasma concentration of IL - 1Plasma concentration of IL - 1 1 day after the surgey
Plasma concentration of Aβ1-42Plasma concentration of Aβ1-42 1 day after the surgey
Plasma concentration of p - TauPlasma concentration of p - Tau 1 day after the surgey

Countries

China

Contacts

Primary ContactYanchao Yang, master
yyc25714104@163.com18940252916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026