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Effects of Methylprednisolone on Immunological Function and Postoperative Pain

NCT03393949 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-12-10

No results posted yet for this study

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

Interventions

DRUG

Methylprednisolone 1 mg•kg-1

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

DRUG

isotonic saline 1mg•kg-1

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

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Junchao Zhu, doctor · professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2016-10-31
Completion
2017-01-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393949 on ClinicalTrials.gov