Effect of Dexamethasone on Postoperative Inflammatory Factors

NCT04981093 | Completed

• 1 other identifier: 2020-519
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation

Keywords

intravenous dexamethasone; inflammation; QoR15; drainage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• the change of blood inflammatory mediators

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

• the change of blood routine white blood cell count

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

Study Arms (2)

Group Dexamethasone

EXPERIMENTAL

Group dexamethasone patients received intravenous injection after anesthesia induction Injection 0.15mg/kg dexamethasone (2ml）

Drug: Dexamethasone Injection

Group Saline

PLACEBO COMPARATOR

Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia

Drug: Normal saline

Interventions

Dexamethasone Injection DRUG

Intravenous injection after induction of anesthesia Injection 0.15mg/kg dexamethasone (2ml)

Group Dexamethasone

Normal saline DRUG

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

Group Saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Related Publications (2)

• 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.

  PMID: 31494615 BACKGROUND

• 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.

  PMID: 33951362 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Calcium Dobesilate; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 28, 2021
• Study Start: August 15, 2021
• Primary Completion: January 1, 2023
• Study Completion: December 30, 2023
• Last Updated: August 14, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)