MethylprednisolonePhase 4NCT03393949
Effects of Methylprednisolone on Immunological Function and Postoperative Pain
A Phase 4 study testing Methylprednisolone 1 mg•kg-1 and isotonic saline 1mg•kg-1 in people with Methylprednisolone and Immunological Function, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Methylprednisolone, Immunological Function, Postoperative Pain
- What is being tested?
- Methylprednisolone 1 mg•kg-1 and isotonic saline 1mg•kg-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2015to 15 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China medical university
Shenyang, Liaoning, 110000
About this study
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
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.
Read the 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.
- Being tested
- Methylprednisolone 1 mg•kg-1, isotonic saline 1mg•kg-1
- Keywords
- Methylprednisolone, Postoperative pain, Immunological function
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 1 mg•kg-1Drug
Patients in Group M received methylprednisolone 1mg•kg-1
isotonic saline 1mg•kg-1Drug
Patients in Group C received isotonic saline 1mg•kg-1
| Study group | Role | What they receive |
|---|---|---|
| Group M | Experimental | Patients in Group M received methylprednisolone 1mg•kg-1 Receives: Drug: Methylprednisolone 1 mg•kg-1 |
| Group C | Experimental | Patients in Group C received isotonic saline 1mg•kg-1 Receives: Drug: isotonic saline 1mg•kg-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, the end of surgery, 24 hours after surgery
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)
Measured: Baseline, the end of surgery, 24 hours after surgery
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)
Measured: Baseline, the end of surgery, 24 hours after surgery
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)
Measured: Baseline, the end of surgery, 24 hours after surgery
Secondary outcomes (2)
postoperative pain score
Tested postoperative pain by using visual analog scale
Measured: 2, 4 6, 24 hours after surgery
Adverse effect
Tested postoperative adverse effect
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jul 2015
- Primary completion31 Oct 2016
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethylprednisoloneStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, doctor, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393949
- Sponsor's protocol ID
- Effects of methylprednisolone
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2016
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03393949
- Acronym / sponsor ID
- Effects of methylprednisolone
- Keywords
- Methylprednisolone, Postoperative pain, Immunological function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Experimental | Drug: Methylprednisolone 1 mg•kg-1Patients in Group M received methylprednisolone 1mg•kg-1 |
| Group C | Experimental | Drug: isotonic saline 1mg•kg-1Patients in Group C received isotonic saline 1mg•kg-1 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone 1 mg•kg-1Patients in Group M received methylprednisolone 1mg•kg-1 | Drug | Group M |
| isotonic saline 1mg•kg-1Patients in Group C received isotonic saline 1mg•kg-1 | Drug | Group C |
Primary outcome
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)
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)
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)
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)
2 secondary outcomes
postoperative pain score
Time frame: 2, 4 6, 24 hours after surgery
Adverse effect
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
Related trials for Methylprednisolone
Not yet recruitingPhase 3
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis
Not yet recruitingPhase 4
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
Shoulder
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
RecruitingPhase 3
Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-Thalassemia
Beta-Thalassemia, Thalassemia
RecruitingPhase 3
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junchao Zhu, doctor study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone 1 mg•kg-1 and isotonic saline 1mg•kg-1 in people with Methylprednisolone and Immunological Function, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of T lymphocyte subsets cluster of differentiation 3(CD3+) (time frame: Baseline, the end of surgery, 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.