Effects of Methylprednisolone on Immunological Function and Postoperative Pain

NCT03393949 | Completed Phase 4 DMC

• 1 other identifier: Effects of methylprednisolone
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Methylprednisolone; Immunological Function; Postoperative Pain

Keywords

Methylprednisolone; Postoperative pain; Immunological function

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  Baseline, the end of surgery, 24 hours after surgery

Secondary Outcomes (2)

• postoperative pain score

  2, 4 6, 24 hours after surgery

• Adverse effect

  24 hours after surgery

Study Arms (2)

Group M

EXPERIMENTAL

Patients in Group M received methylprednisolone 1mg•kg-1

Drug: Methylprednisolone 1 mg•kg-1

Group C

EXPERIMENTAL

Patients in Group C received isotonic saline 1mg•kg-1

Drug: isotonic saline 1mg•kg-1

Interventions

Methylprednisolone 1 mg•kg-1 DRUG

Patients in Group M received methylprednisolone 1mg•kg-1

Group M

isotonic saline 1mg•kg-1 DRUG

Patients in Group C received isotonic saline 1mg•kg-1

Group C

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Junchao Zhu, doctor

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 9, 2018
• Study Start: July 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: January 15, 2017
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

CN (1)