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Effects of Methylprednisolone on Immunological Function and Postoperative Adverse Reaction in Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT03393949
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yanchao Yang, Shengjing Hospital

Brief Summary:
Lung cancer, of which incidence has been on the top of the list of male tumors, is a familiar carcinoma in respiratory system.Resection surgery has been the best approach for patients in early period. However, long duration and huge operative trauma lead to the decrease of immunological function of cancer patients, in addition, stress reaction in perioperative period, application of different anaesthetics during general anesthesia and postoperative pain can also affect the immunological function in varying degrees, increase the incidence of postoperative adversities.This study aims at discussing the effects on immunological function, cognitive function and postoperative adversities of elderly lung cancer patients after resection surgery caused by different doses of methylprednisolone in the single use.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Drug: Methylprednisolone 1 mg•kg-1 Drug: Methylprednisolone 0.5mg•kg-1 Phase 4

Detailed Description:
80 cases of patients undergoing general anesthesia during radical resection of lung cancer by thoracoscope, American Society of Anesthesiologists (ASA) physical status II~III, male or female, age between 65 and 85 years old,randomly divided into 2 groups (M and C) ,each group with 40 cases. In group M, each one was given methylprednisolone at 1mg•kg-1 before surgery, dexmedetomidine i.v at 1ug/kg was conducted 10 minutes before anesthesia induction, and pumped in at 0.5ug•kg-1h-1 constantly during the surgery, withdrew the drug 30 minutes before the surgery was done. In group C, methylprednisolone was administrated at 0.5 mg•kg-1 before surgery, dexmedetomidine i.v at 1ug/kg was conducted 10 minutes before anesthesia induction, and pumped in at 0.5ug•kg-1h-1 constantly during the surgery, withdrew the drug 30 minutes before the surgery was done. Assessed postoperative cognitive function of patients by Mini-mental State Examination Score marking scales on the day before surgery, the first day and third day after surgery, decided whether postoperative cognitive dysfunction was happened, postoperative adversities such as vomit, nausea and other special circumstances were recorded. Drew venous blood before the induction (T0), right after surgery (T1), 24h after surgery (T2), tested the levels of T cell subsets such as CD3+、CD4+、CD8+ with flow cytometry, calculated the ratio of CD4+/CD8+. Tested concentration of NSE、s100βin serum.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Different Doses of Methylprednisolone on Immunological Function and Postoperative Adverse Reaction of Patients After Radical Resection of Lung Cancer by Thoracoscope
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : January 15, 2017


Arm Intervention/treatment
Experimental: Group M
Patients in Group M received methylprednisolone 1mg•kg-1
Drug: Methylprednisolone 1 mg•kg-1
Patients in Group M received methylprednisolone 1mg•kg-1
Other Name: methylprednisolone sodium succinate

Experimental: Group C
Patients in Group C received methylprednisolone 0.5mg•kg-1
Drug: Methylprednisolone 0.5mg•kg-1
Patients in Group C received methylprednisolone 0.5mg•kg-1
Other Name: methylprednisolone sodium succinate




Primary Outcome Measures :
  1. Change in the level of T lymphocyte subsets cluster of differentiation 3(CD3+) [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Tested the level of CD3+ with flow cytometry at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)

  2. Change in the level of T lymphocyte subsets cluster of differentiation 4(CD4+) [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Tested the level of CD4+ with flow cytometry at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)

  3. Change in the level of T lymphocyte subsets cluster of differentiation 8(CD8+) [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Tested the level of CD4+ with flow cytometry at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)

  4. The ratio of T lymphocyte subsets cluster of differentiation 4(CD4+)/ T lymphocyte subsets cluster of differentiation 8(CD8+) [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Calculated the ratio of CD4+/CD8+ at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)


Secondary Outcome Measures :
  1. Change in the concentration of neuron-specific enolase(NSE) [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Tested the concentration of NSE by ELISA at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)

  2. Change in the concentration of s100β [ Time Frame: Baseline, the end of surgery, 24 hours after surgery ]
    Tested concentration of s100β by ELISA at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)

  3. Change in the Mini-mental State Examination Score [ Time Frame: the day before surgery, the day after surgery, the third day after surgery. ]
    Record the Mini-mental State Examination Score of patients on the day before surgery, the day after surgery and the third day after surgery.

  4. The incidence of postoperative cognitive dysfunction(POCD) [ Time Frame: From the day before surgery to the third day after surgery ]
    Used Mini-mental State Examination Score to assess the incidence of POCD


Other Outcome Measures:
  1. The incidence of Hypoxemia, Nausea and Vomiting, Chill and Dysphoria [ Time Frame: up to third day after surgery ]
    Investigate the incidence of Hypoxemia, Nausea and Vomiting, Chill and Dysphoria within 3days after surgery



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Ⅱ~Ⅲ
  • aged 65—85years
  • consciousness,with no psychological or communication disorders, with educational level above primary school (including primary school).
  • with no chemotherapy or radiotherapy before admission.
  • no history of medicine allergy.
  • no evident abnormality of liver, kidney or nervous system
  • scheduled for radical operation for lung cancer under general anesthesia

Exclusion Criteria:

  • diagnosed with diseases in nervous system or psychological disorder, history of taking sedatives or anti-depressants.
  • history of hypertension, diabetes, coronary heart disease, cerebral infarction.
  • had drugs which affect immunological function before.
  • severe acuity or vision dysfunction or have difficulty in communication.
  • with special complications during surgery.
  • had blood transfusion treatment during perioperation period history of heart operation
  • Mini-mental State Examination Scores less than 25 before surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393949


Locations
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China, Liaoning
Shengjing hospital of China medical university
Shenyang, Liaoning, China, 110000
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Study Director: Junchao Zhu, doctor professor

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Responsible Party: Yanchao Yang, resident doctor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03393949     History of Changes
Other Study ID Numbers: Effects of methylprednisolone
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by Yanchao Yang, Shengjing Hospital:
Methylprednisolone
Postoperative cognitive function
Immunological function
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents