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NCT Number: NCT03393949

Effects of Methylprednisolone on Immunological Function and Postoperative Pain

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shengjing hospital of China medical university

Shenyang, Liaoning, 110000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylprednisolone 1 mg•kg-1

Drug

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

isotonic saline 1mg•kg-1

Drug

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

Primary outcomes

  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 outcomes

  1. postoperative pain score

    Time frame: 2, 4 6, 24 hours after surgery

    Tested postoperative pain by using visual analog scale

  2. Adverse effect

    Time frame: 24 hours after surgery

    Tested postoperative adverse effect

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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