Effect of Dexamethasone on Postoperative Inflammatory Factors

NCT ID: NCT04981093

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2023-12-30

Brief Summary

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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

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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

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group Dexamethasone

Group dexamethasone patients received intravenous injection after anesthesia induction

Injection 0.15mg/kg dexamethasone (2ml)

Group Type EXPERIMENTAL

Dexamethasone Injection

Intervention Type DRUG

Intravenous injection after induction of anesthesia

Injection 0.15mg/kg dexamethasone (2ml)

Group Saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Dexamethasone Injection

Intravenous injection after induction of anesthesia

Injection 0.15mg/kg dexamethasone (2ml)

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31494615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33951362 (View on PubMed)

Other Identifiers

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2020-519

Identifier Type: -

Identifier Source: org_study_id

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