Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06405659
Other study ID # YJLW2019001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 6, 2018
Est. completion date September 30, 2023

Study information

Verified date April 2024
Source Affiliated Hospital of Guangdong Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - N/A Exclusion Criteria: - N/A

Study Design


Intervention

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

Locations

Country Name City State
China The Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Guangdong Medical University

Country where clinical trial is conducted

China, 

References & Publications (39)

Aarnes TK, Bednarski RM, Lerche P, Hubbell JA. Effect of pre-warming on perioperative hypothermia and anesthetic recovery in small breed dogs undergoing ovariohysterectomy. Can Vet J. 2017 Feb;58(2):175-179. — View Citation

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

Anetseder M, Hager M, Muller CR, Roewer N. Diagnosis of susceptibility to malignant hyperthermia by use of a metabolic test. Lancet. 2002 May 4;359(9317):1579-80. doi: 10.1016/S0140-6736(02)08506-9. — View Citation

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. — View Citation

Bajwa SJ, Gupta S, Kaur J, Singh A, Parmar S. Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomized prospective study. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):86-91. doi: 10.4103/0970-9185.92452. — View Citation

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. — View Citation

Carr DB, Bergland R, Hamilton A, Blume H, Kasting N, Arnold M, Martin JB, Rosenblatt M. Endotoxin-stimulated opioid peptide secretion: two secretory pools and feedback control in vivo. Science. 1982 Aug 27;217(4562):845-8. doi: 10.1126/science.6285473. — View Citation

Cheon YM, Yoon H. [The Effects of 30-Minutes of Pre-Warming on Core Body Temperature, Systolic Blood Pressure, Heart Rate, Postoperative Shivering, and Inflammation Response in Elderly Patients with Total Hip Replacement under Spinal Anesthesia: A Randomized Double-blind Controlled Trial]. J Korean Acad Nurs. 2017 Aug;47(4):456-466. doi: 10.4040/jkan.2017.47.4.456. Korean. — View Citation

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. — View Citation

Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181. — View Citation

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. — View Citation

Ezhevskaya AA, Mlyavykh SG, Anderson DG. Effects of continuous epidural anesthesia and postoperative epidural analgesia on pain management and stress response in patients undergoing major spinal surgery. Spine (Phila Pa 1976). 2013 Jul 1;38(15):1324-30. doi: 10.1097/BRS.0b013e318290ff26. — View Citation

Feketa VV, Zhang Y, Cao Z, Balasubramanian A, Flores CM, Player MR, Marrelli SP. Transient receptor potential melastatin 8 channel inhibition potentiates the hypothermic response to transient receptor potential vanilloid 1 activation in the conscious mouse. Crit Care Med. 2014 May;42(5):e355-63. doi: 10.1097/CCM.0000000000000229. — View Citation

Fujita T, Okada N, Kanamori J, Sato T, Mayanagi S, Torigoe K, Oshita A, Yamamoto H, Daiko H. Thermogenesis induced by amino acid administration prevents intraoperative hypothermia and reduces postoperative infectious complications after thoracoscopic esophagectomy. Dis Esophagus. 2017 Jan 1;30(1):1-7. doi: 10.1111/dote.12460. — View Citation

Gray RM. Anesthesia-induced rhabdomyolysis or malignant hyperthermia: is defining the crisis important? Paediatr Anaesth. 2017 May;27(5):490-493. doi: 10.1111/pan.13130. Epub 2017 Mar 17. — View Citation

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. — View Citation

Lee WP, Wu PY, Shih WM, Lee MY, Ho LH. The effectiveness of the newly designed thermal gown on hypothermic patients after spinal surgery. J Clin Nurs. 2015 Oct;24(19-20):2779-87. doi: 10.1111/jocn.12873. Epub 2015 Jul 5. — View Citation

Lenhardt R. The effect of anesthesia on body temperature control. Front Biosci (Schol Ed). 2010 Jun 1;2(3):1145-54. doi: 10.2741/s123. — View Citation

Li J, Dong B, Hao D. [Clinical therapeutic effect of dexmedetomidine on patients during the extubation period of general anesthesia]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Aug;40(8):898-901. doi: 10.11817/j.issn.1672-7347.2015.08.012. Chinese. — View Citation

Lopez MB. Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum. — View Citation

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

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. — View Citation

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. — View Citation

Ren Z, He S, Li J, Wang Y, Lai J, Sun Z, Feng H, Wang J. Comparison of the Safety and Effectiveness of Percutaneous Endoscopic Lumbar Discectomy for Treating Lumbar Disc Herniation Under Epidural Anesthesia and General Anesthesia. Neurospine. 2020 Mar;17(1):254-259. doi: 10.14245/ns.1938366.183. Epub 2020 Feb 1. — View Citation

Ryan KF, Price JW, Warriner CB, Choi PT. Persistent hypothermia after intrathecal morphine: case report and literature review. Can J Anaesth. 2012 Apr;59(4):384-8. doi: 10.1007/s12630-011-9650-z. Epub 2011 Dec 10. — View Citation

Sadrolsadat SH, Mahdavi AR, Moharari RS, Khajavi MR, Khashayar P, Najafi A, Amirjamshidi A. A prospective randomized trial comparing the technique of spinal and general anesthesia for lumbar disk surgery: a study of 100 cases. Surg Neurol. 2009 Jan;71(1):60-5; discussion 65. doi: 10.1016/j.surneu.2008.08.003. — View Citation

Santa Maria PL, Santa Maria C, Eisenried A, Velasquez N, Kannard BT, Ramani A, Kahn DM, Wheeler AJ, Brock-Utne JG. A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy. BMC Anesthesiol. 2017 Aug 11;17(1):102. doi: 10.1186/s12871-017-0395-2. — View Citation

Seo J, Park JH, Song EH, Lee YS, Jung SK, Jeon SR, Rhim SC, Roh SW. Postoperative Nonpathologic Fever After Spinal Surgery: Incidence and Risk Factor Analysis. World Neurosurg. 2017 Jul;103:78-83. doi: 10.1016/j.wneu.2017.03.119. Epub 2017 Apr 2. — View Citation

Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8. — View Citation

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. Erratum In: JAMA. 2016 May 24-31;315(20):2237. — View Citation

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. — View Citation

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. — View Citation

Steelman VM, Chae S, Duff J, Anderson MJ, Zaidi A. Warming of Irrigation Fluids for Prevention of Perioperative Hypothermia During Arthroscopy: A Systematic Review and Meta-analysis. Arthroscopy. 2018 Mar;34(3):930-942.e2. doi: 10.1016/j.arthro.2017.09.024. Epub 2017 Dec 6. — View Citation

Tan CL, Cooke EK, Leib DE, Lin YC, Daly GE, Zimmerman CA, Knight ZA. Warm-Sensitive Neurons that Control Body Temperature. Cell. 2016 Sep 22;167(1):47-59.e15. doi: 10.1016/j.cell.2016.08.028. Epub 2016 Sep 8. — View Citation

Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17. — View Citation

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. — View Citation

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. — View Citation

Zeba S, Surbatovic M, Marjanovic M, Jevdjic J, Hajdukovic Z, Karkalic R, Jovanovic D, Radakovic S. Efficacy of external warming in attenuation of hypothermia in surgical patients. Vojnosanit Pregl. 2016 Jun;73(6):566-71. doi: 10.2298/vsp150330032z. — View Citation

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. — View Citation

* Note: There are 39 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary surgical complication Complications related to the surgical procedure up to 3 years, after surgical procedure
See also
  Status Clinical Trial Phase
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03706599 - Fever Infants and Therapeutic Education in Emergency Department N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT01782183 - Thermographic Characteristics of Sore Throat by Thermographic Camera N/A
Withdrawn NCT00800696 - Preventive Oral Care N/A
Completed NCT02689193 - IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Completed NCT02212990 - The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine N/A
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01869699 - Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults Phase 4
Completed NCT01194557 - Introducing Rapid Diagnostic Tests Into the Private Health Sector N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Completed NCT00940654 - The Fever and Antipyretic in Critically Illness Evaluation Study N/A
Completed NCT00969176 - Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates Phase 2/Phase 3
Recruiting NCT00729976 - Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study. Phase 4
Recruiting NCT00389272 - Adding a Second Drug for Febrile Children Treated With Acetaminophen N/A
Completed NCT00257790 - The Tobramycin Study Phase 4
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Completed NCT02595827 - Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo Phase 3
Recruiting NCT06061575 - Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients Phase 4
Recruiting NCT06038617 - Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children Phase 4