Effect of Dexamethasone on Postoperative Inflammatory Factors

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Drug: Dexamethasone Injection; Drug: Normal saline

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Dexamethasone; Group dexamethasone patients received intravenous injection after anesthesia induction Injection 0.15mg/kg dexamethasone (2ml）	Drug: Dexamethasone Injection; Intravenous injection after induction of anesthesia Injection 0.15mg/kg dexamethasone (2ml)
Placebo Comparator: Group Saline; Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia	Drug: Normal saline; 2ml of normal saline was injected intravenously after induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of drainage fluid volume	Drainage fluid （ml）was collected and the volume of drainage fluid was recorded Until the drainage tube was pulled out,	6 hours after surgery， the morning of 1, 2, and 3 days after surgery
the change of Inflammatory mediators in the drainage fluid	CRP(mg/ L) in postoperative drainage fluid was observed	6 hours after surgery， the morning of 1, 2, and 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of blood inflammatory mediators	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)	6 hours after surgery， the morning of 1, 2, and 3 days after surgery
the change of blood routine white blood cell count	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	6 hours after surgery， the morning of 1, 2, and 3 days after surgery

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Publications and helpful links

General Publications

• Corcoran TB, Myles PS, Forbes AB, O'Loughlin E, Leslie K, Story D, Short TG, Chan MT, Coutts P, Sidhu J, Cheng AC, Bach LA, Ho KM; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network. The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study. BMJ Open. 2019 Sep 6;9(9):e030402. doi: 10.1136/bmjopen-2019-030402.
• Corcoran TB, Myles PS, Forbes AB, Cheng AC, Bach LA, O'Loughlin E, Leslie K, Chan MTV, Story D, Short TG, Martin C, Coutts P, Ho KM; PADDI Investigators; Australian and New Zealand College of Anaesthetists Clinical Trials Network; Australasian Society for Infectious Diseases Clinical Research Network. Dexamethasone and Surgical-Site Infection. N Engl J Med. 2021 May 6;384(18):1731-1741. doi: 10.1056/NEJMoa2028982.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: inflammation; drainage; QoR15; intravenous dexamethasone
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone acetate
• Other Study ID Numbers: 2020-519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No