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FeverNCT06405659

Immediate Fever During Anaesthesia Recovery After Surgical Procedure With Scoliosis

An observational study of Fever and Scoliosis, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fever is a common clinical symptom in patients with postoperative scoliosis. However, there are rare reports of immediately fevers occurring following operative procedures. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Fever, Scoliosis, Surgical Trauma
What is being tested?
correction for pedicle fixation
How many people
1 participants
Where
1 siteChina
Study dates
6 Aug 2018to 30 Sep 2023
Phase
Observational
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: A 15-year-old female with a 1-year history of scoliosis was admitted to the hospital after a health examination.

Who may be able to join

  • N/A

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

Other trials in China

About this study

Official title: Immediate Fever During Anaesthesia Recovery After Surgical Procedure With Scoliosis: A Case Report and Literature Review

Fever is a common clinical symptom in patients with postoperative scoliosis. However, there are rare reports of immediately fevers occurring following operative procedures.

Read the detailed description

Postoperative fever is a common clinical symptom in patients following spinal surgery, with an incidence of 13.2%, and 64.5% of patients with neuromuscular scoliosis were observed to develop postoperative fevers. The most frequently observed cause of fever is surgical trauma, which is associated with inflammatory responses to surgery, and such fevers typically resolve within 2-3 days. This self-limited cause of postoperative fever is non-pathological,4 and the severity and duration of such fevers depend on the duration, scope, and type of surgery, and whether a mesh graft was inserted. The aetiology of immediate postoperative fever for patients following hip prosthesis implantation is unknown, and it is inexpedient to initiate antibiotic treatment or to increase the prophylactic antibiotic dosage. However, there are rare reports of chills and fevers occurring immediately following spinal surgery, to the best of our knowledge, there have been no reports on the mechanism of immediate postoperative fever following spinal surgery.

Based on this evidence and on observation, when patients experience postoperative fevers, nearly all surgeons seek to exclude infection as a cause. The case presented in this paper is that of a 15-year-old female with idiopathic scoliosis who underwent posterior idiopathic scoliosis incision and correction for pedicle fixation. The clinical symptoms of interest, including chills, a high fever, an increased heart rate and increased blood pressure, were observed immediately during the course of anaesthesia resuscitation. In this report, risk factors, treatment and prevention are assessed based on the case evidence.

Being tested
correction for pedicle fixation
Medical subject headings
Fever, Scoliosis, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • correction for pedicle fixationOther

    The patient was diagnosed with idiopathic scoliosis and underwent a posterior idiopathic scoliosis procedure and correction for pedicle fixation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surgical complication

    Complications related to the surgical procedure

    Measured: up to 3 years, after surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start6 Aug 2018
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06405659
Sponsor's protocol ID
YJLW2019001
Status last verified
Apr 2024
First submitted
24 Apr 2024
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The raw data for this case and related of cases can be obtained from corresponding authors YYZ by e-mail.

Publications

  • Yousef MAA, Rosenfeld S. Evaluation of postoperative fever after surgical correction of neuromuscular scoliosis: implication on management. Eur Spine J. 2018 Aug;27(8):1690-1697. doi: 10.1007/s00586-017-5456-1. Epub 2018 Jan 9.

    PubMed 29318413

  • Petretta R, McConkey M, Slobogean GP, Handel J, Broekhuyse HM. Incidence, risk factors, and diagnostic evaluation of postoperative fever in an orthopaedic trauma population. J Orthop Trauma. 2013 Oct;27(10):558-62. doi: 10.1097/BOT.0b013e31828af4df.

    PubMed 23412504

  • Blumstein GW, Andras LM, Seehausen DA, Harris L, Ross PA, Skaggs DL. Fever is common postoperatively following posterior spinal fusion: infection is an uncommon cause. J Pediatr. 2015 Mar;166(3):751-5. doi: 10.1016/j.jpeds.2014.11.033. Epub 2015 Jan 6.

    PubMed 25575423

  • Clark JA, Bar-Yosef S, Anderson A, Newman MF, Landolfo K, Grocott HP. Postoperative hyperthermia following off-pump versus on-pump coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2005 Aug;19(4):426-9. doi: 10.1053/j.jvca.2005.01.042.

    PubMed 16085244

  • Sharp NE, Alemayehu H, Desai A, Holcomb GW 3rd, St Peter SD. Fever after redo Nissen fundoplication with hiatal hernia repair. J Surg Res. 2014 Aug;190(2):594-7. doi: 10.1016/j.jss.2014.05.021. Epub 2014 May 14.

    PubMed 24948540

  • Zhao Z, Ma X, Ma J, Sun X, Li F, Lv J. A Systematic Review and Meta-analysis of the Topical Administration of Fibrin Sealant in Total Hip Arthroplasty. Sci Rep. 2018 Jan 8;8(1):78. doi: 10.1038/s41598-017-16779-3.

    PubMed 29311570

  • Badillo AT, Sarani B, Evans SR. Optimizing the use of blood cultures in the febrile postoperative patient. J Am Coll Surg. 2002 Apr;194(4):477-87; quiz 554-6. doi: 10.1016/s1072-7515(02)01115-8. No abstract available.

    PubMed 11949753

  • de la Torre SH, Mandel L, Goff BA. Evaluation of postoperative fever: usefulness and cost-effectiveness of routine workup. Am J Obstet Gynecol. 2003 Jun;188(6):1642-7. doi: 10.1067/mob.2003.397.

    PubMed 12825005

  • Walid MS, Sahiner G, Robinson C, Robinson JS 3rd, Ajjan M, Robinson JS Jr. Postoperative fever discharge guidelines increase hospital charges associated with spine surgery. Neurosurgery. 2011 Apr;68(4):945-9; discussion 949. doi: 10.1227/NEU.0b013e318209c80a.

    PubMed 21242842

  • Krishnan SS, Nigam P, Bachh O, Vasudevan MC. Quad Fever: Treatment through Lowering of Ambient Temperature. Indian J Crit Care Med. 2018 Jan;22(1):43-45. doi: 10.4103/ijccm.IJCCM_295_17.

    PubMed 29422733

  • Abeysinghe P, Ekanayake H, Ranasinghe J. Transfusion related acute lung injury (TRALI)-a case report. Vox Sanguinis 2017; 112: 273.

  • Pile JC. Evaluating postoperative fever: a focused approach. Cleve Clin J Med. 2006 Mar;73 Suppl 1:S62-6. doi: 10.3949/ccjm.73.suppl_1.s62.

    PubMed 16570551

  • Sloan TB, Myers G, Janik DJ, Burger EM, Patel VV, Jameson LC. Intraoperative autologous transfusion of hemolyzed blood. Anesth Analg. 2009 Jul;109(1):38-42. doi: 10.1213/ane.0b013e3181a335e4.

    PubMed 19535693

  • Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288.

    PubMed 26903335

  • MacLennan DH, Phillips MS. Malignant hyperthermia. Science. 1992 May 8;256(5058):789-94. doi: 10.1126/science.1589759.

    PubMed 1589759

Questions about this trial

What is this clinical trial studying?

An observational study of Fever and Scoliosis, run by Affiliated Hospital of Guangdong 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 1 inclusion and 1 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 8 May 2024. 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. 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?

surgical complication (time frame: up to 3 years, after surgical procedure). 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 NCT06405659, which also lists 39 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 8 May 2024.

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