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NCT Number: NCT04981093

Effect of Dexamethasone on Postoperative Inflammatory Factors

This topic foe randomized prospective study.Detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

About this study

A total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group C,n=50) and dexamethasone group (group D,n=50). Group D was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. Group C was also intravenously injected with 2ml normal saline after anesthesia induction.On this basis, monitor the main results and secondary results

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients ≥65years of age
  • American Society of Anesthesiologists (ASA) physical status 2-4
  • Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia
  • Requiring a hospital stay of at least one postoperative night
  • A surgical skin incision >5 cm in length or multiple incisions with a total incision length of >5 cm

Exclusion criteria

·

  • Poorly controlled diabetes (HbA1c>9.0%)
  • Endovascular procedure with a small (<5 cm length) skin incision Ophthalmic surgery
  • Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
  • Recent (<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics
  • Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)

Treatment and study plan

Dexamethasone Injection

Drug

Intravenous injection after induction of anesthesia

Injection 0.15mg/kg dexamethasone (2ml)

normal saline

Drug

2ml of normal saline was injected intravenously after induction of anesthesia

Primary outcomes

  1. the change of drainage fluid volume

    Time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery

    Drainage fluid （ml）was collected and the volume of drainage fluid was recorded

    Until the drainage tube was pulled out,

  2. the change of Inflammatory mediators in the drainage fluid

    Time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery

    CRP(mg/ L) in postoperative drainage fluid was observed

Secondary outcomes

  1. the change of blood inflammatory mediators

    Time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery

    Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery

    Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique

    After the blood CRP(mg/l)

  2. the change of blood routine white blood cell count

    Time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery

    Fasting blood was collected from each enrolled patient preoperatively, 6 hours after surgery and on the morning of 1, 2, and 3 days after surgery

    Fasting blood, blood samples were centrifuged (1500r/min, 15min) and serum was separated and placed in -80℃ deep low temperature refrigerator for measurement. The observation technique

    After the blood blood routine white blood cell count

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
Aug 14, 2025

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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