Effect of Dexamethasone on Postoperative Inflammatory Factors

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981093
• Other study ID #: 2020-519
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2021
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Dexamethasone Injection
Intravenous injection after induction of anesthesia Injection 0.15mg/kg dexamethasone (2ml)
• Normal saline
2ml of normal saline was injected intravenously after induction of anesthesia

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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