Effects of Methylprednisolone on Immunological Function and Postoperative Pain
Primary Purpose
Methylprednisolone, Immunological Function, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone 1 mg•kg-1
isotonic saline 1mg•kg-1
Sponsored by

About this trial
This is an interventional treatment trial for Methylprednisolone focused on measuring Methylprednisolone, Postoperative pain, Immunological function
Eligibility 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.
Sites / Locations
- Shengjing hospital of China medical university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group M
Group C
Arm Description
Patients in Group M received methylprednisolone 1mg•kg-1
Patients in Group C received isotonic saline 1mg•kg-1
Outcomes
Primary Outcome Measures
Change in the level of T lymphocyte subsets cluster of differentiation 3(CD3+)
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)
Change in the level of T lymphocyte subsets cluster of differentiation 4(CD4+)
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)
Change in the level of T lymphocyte subsets cluster of differentiation 8(CD8+)
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)
The ratio of T lymphocyte subsets cluster of differentiation 4(CD4+)/ T lymphocyte subsets cluster of differentiation 8(CD8+)
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
postoperative pain score
Tested postoperative pain by using visual analog scale
Adverse effect
Tested postoperative adverse effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03393949
Brief Title
Effects of Methylprednisolone on Immunological Function and Postoperative Pain
Official Title
Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgical trauma is characterized by a tightly integrated sequence of neurohumoral and immunological processes. When this is marked, it can manifest as a clinical entity called the systemic inflammatory response syndrome. Previous studies reported that inflammatory milieu in the postoperative period can be a harmful and potentially modifiable condition that may affect postoperative recovery, which includes the level of pain, fatigue, dizziness, nausea and vomiting (PONV), muscle weakness, and sleep quality and then increases the need for hospitalization. The effect of postoperative inflammation-related immune suppression such as the T-cell exhaustion and lymphocyte anergy may render the patient vulnerable to both infection and the recurrence of malignancy on postoperative infection risk and malignancy recurrence are currently subjects of intense speculation and investigation.
Glucocorticoids are well known for their analgesic, anti-inflammatory, immunosuppressive agents and antiemetic effects. Though previous studies' results on postoperative outcome have been positive and in favor of glucocorticoid use, with postoperative nausea and vomiting and pain outcome parameters most significantly improved. However, high-dose methylprednisolone treatment could result in decreases T-cells postoperatively. Based on these consideration, the aim of our study was to assess the effect of a single low-dose preoperative methylprednisolone (MP) 1 mg/Kg i.v. on postoperative pain and immune functions in patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.
Detailed Description
The eighty-one patients were randomly assigned either to the MP Group or the Control Group in a 1:1 ratio using a computer-generated randomization number sequence. The group assignment was sealed in sequentially numbered opaque envelopes. No stratification or block randomization was made. The envelopes were opened on the morning of surgery, and the trial drug was prepared by a senior anaesthetist not otherwise involved in data collection. The MP group received a single-dose of MP, 1 mg/Kg i.v. (Solu-Medrolw; Pfizer, Ballerup, Denmark) and the Control group a single-dose of isotonic saline ( equal capacity with MP) i.v. The test solution was administered just 30 mins before the operation. The patients, attending anesthesiologists, surgeons, and data collectors were all blinded to patient group assignment.The primary outcomes of the levels of T lymphocyte subsets of CD3+, CD4+, and CD8+, and the CD4+/CD8+ ratio were measured at T0, T1, and T2. Postoperative pain scores were evaluated by the visual analog scale (VAS) score16, where 0 indicates painlessness, and 10 indicates severe pain. The patients were asked to evaluate their pain at rest and during coughing at 2, 4, 6, and 24 hours postoperatively. Total pump press numbers of PCA and adverse effects during 24 hours after surgery such as hypotension, bradycardia, nausea and vomiting, and dizzy were recorded and treated accordingly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methylprednisolone, Immunological Function, Postoperative Pain
Keywords
Methylprednisolone, Postoperative pain, Immunological function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group M
Arm Type
Experimental
Arm Description
Patients in Group M received methylprednisolone 1mg•kg-1
Arm Title
Group C
Arm Type
Experimental
Arm Description
Patients in Group C received isotonic saline 1mg•kg-1
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone 1 mg•kg-1
Intervention Description
Patients in Group M received methylprednisolone 1mg•kg-1
Intervention Type
Drug
Intervention Name(s)
isotonic saline 1mg•kg-1
Intervention Description
Patients in Group C received isotonic saline 1mg•kg-1
Primary Outcome Measure Information:
Title
Change in the level of T lymphocyte subsets cluster of differentiation 3(CD3+)
Description
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)
Time Frame
Baseline, the end of surgery, 24 hours after surgery
Title
Change in the level of T lymphocyte subsets cluster of differentiation 4(CD4+)
Description
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)
Time Frame
Baseline, the end of surgery, 24 hours after surgery
Title
Change in the level of T lymphocyte subsets cluster of differentiation 8(CD8+)
Description
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)
Time Frame
Baseline, the end of surgery, 24 hours after surgery
Title
The ratio of T lymphocyte subsets cluster of differentiation 4(CD4+)/ T lymphocyte subsets cluster of differentiation 8(CD8+)
Description
Calculated the ratio of CD4+/CD8+ at the time points of pre-induction (T0), the end of surgery (T1) and 24h after surgery (T2)
Time Frame
Baseline, the end of surgery, 24 hours after surgery
Secondary Outcome Measure Information:
Title
postoperative pain score
Description
Tested postoperative pain by using visual analog scale
Time Frame
2, 4 6, 24 hours after surgery
Title
Adverse effect
Description
Tested postoperative adverse effect
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu, doctor
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing hospital of China medical university
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
12. IPD Sharing Statement
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Effects of Methylprednisolone on Immunological Function and Postoperative Pain
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