Clinical trial NCT04981093: Effect of Dexamethasone on Postoperative Inflammatory Factors
Official title: Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Keywords: intravenous dexamethasone
inflammation
QoR15
drainage
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: the change of drainage fluid volume
timeFrame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
measure: the change of Inflammatory mediators in the drainage fluid
timeFrame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Secondary outcomes:
measure: the change of blood inflammatory mediators
timeFrame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
measure: the change of blood routine white blood cell count
timeFrame: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
References:
citation: 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.
citation: 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.