InflammationNCT04981093
Effect of Dexamethasone on Postoperative Inflammatory Factors
A study testing Dexamethasone Injection and Normal saline in people with Inflammation, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- Dexamethasone Injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: 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.
Read the 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
- Conditions
- Inflammation
- Being tested
- Dexamethasone Injection, Normal saline
- Keywords
- intravenous dexamethasone, inflammation, QoR15, drainage
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone InjectionDrug
Intravenous injection after induction of anesthesia
Injection 0.15mg/kg dexamethasone (2ml)
Normal salineDrug
2ml of normal saline was injected intravenously after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Dexamethasone | Experimental | Group dexamethasone patients received intravenous injection after anesthesia induction
Injection 0.15mg/kg dexamethasone (2ml） Receives: Drug: Dexamethasone Injection |
| Group Saline | Placebo comparator | Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
Measured: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Secondary outcomes (2)
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)
Measured: 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
Measured: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Aug 2021
- Primary completion1 Jan 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981093
- Sponsor's protocol ID
- 2020-519
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31494615Corcoran 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.
PubMed 33951362
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04981093
- Acronym / sponsor ID
- 2020-519
- Conditions
- Inflammation
- Keywords
- intravenous dexamethasone, inflammation, QoR15, drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexamethasone | Experimental | Drug: Dexamethasone InjectionGroup dexamethasone patients received intravenous injection after anesthesia induction Injection 0.15mg/kg dexamethasone (2ml） |
| Group Saline | Placebo comparator | Drug: Normal salineGroup Control patients were also given 2ml of normal saline intravenously after induction of anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone InjectionIntravenous injection after induction of anesthesia Injection 0.15mg/kg dexamethasone (2ml) | Drug | Group Dexamethasone |
| Normal saline2ml of normal saline was injected intravenously after induction of anesthesia | Drug | Group Saline |
Primary outcome
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,
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
2 secondary outcomes
the change of blood inflammatory mediators
Time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 31494615Corcoran 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.
- Background: PubMed 33951362Corcoran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Injection and Normal saline in people with Inflammation, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of drainage fluid volume (time frame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.