Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-08-20
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Reinflation after early deflation
The tourniquet would be inflated immediately before incision and deflated after the use of the cement, and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes.
Reinflation after early deflation
the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.
Control
The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
Control
The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Reinflation after early deflation
the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.
Control
The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing unilateral total knee arthroplasty under general anesthesia
* Should be treated with tourniquet
Exclusion Criteria
* Abnormal coagulation function
* BMI \< 20kg/m2 or \> 35kg/m2
* History of cerebral infarction
* History of Peripheral vascular disease
* Anemia (hemoglobin\<90g/L)
* Systolic blood pressure (SBP) ≥ 170mmHg
* Pregnant blood glucose \> 10mmol/L or HbA1c \> 8.5% of diabetic patients
* History of chronic narcotic use
* Participate in other clinical trials at the same time
* Asked to withdraw from the trial
45 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guanglei Wang, MD
Role: STUDY_DIRECTOR
The Affiliated Hospital of Xuzhou Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Guanglei Wang, MD
Role: primary
Pei Liu, Bachelor
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Rama KR, Apsingi S, Poovali S, Jetti A. Timing of tourniquet release in knee arthroplasty. Meta-analysis of randomized, controlled trials. J Bone Joint Surg Am. 2007 Apr;89(4):699-705. doi: 10.2106/JBJS.F.00497.
Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.
Silver R, de la Garza J, Rang M, Koreska J. Limb swelling after release of a tourniquet. Clin Orthop Relat Res. 1986 May;(206):86-9.
Butt U, Ahmad R, Aspros D, Bannister GC. Factors affecting wound ooze in total knee replacement. Ann R Coll Surg Engl. 2011 Jan;93(1):54-6. doi: 10.1308/003588410X12771863937124. Epub 2010 Sep 10.
Palmer SH, Graham G. Tourniquet-induced rhabdomyolysis after total knee replacement. Ann R Coll Surg Engl. 1994 Nov;76(6):416-7.
Gielen MJ, Stienstra R. Tourniquet hypertension and its prevention: a review. Reg Anesth. 1991 Jul-Aug;16(4):191-4. No abstract available.
Kaufman RD, Walts LF. Tourniquet-induced hypertension. Br J Anaesth. 1982 Mar;54(3):333-6. doi: 10.1093/bja/54.3.333.
Valli H, Rosenberg PH. Effects of three anaesthesia methods on haemodynamic responses connected with the use of thigh tourniquet in orthopaedic patients. Acta Anaesthesiol Scand. 1985 Jan;29(1):142-7. doi: 10.1111/j.1399-6576.1985.tb02175.x.
Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.
Bostankolu E, Ayoglu H, Yurtlu S, Okyay RD, Erdogan G, Deniz Y, Hanci V, Can M, Turan IO. Dexmedetomidine did not reduce the effects of tourniquet-induced ischemia-reperfusion injury during general anesthesia. Kaohsiung J Med Sci. 2013 Feb;29(2):75-81. doi: 10.1016/j.kjms.2012.08.013. Epub 2012 Oct 13.
Lin L, Wang L, Bai Y, Zheng L, Zhao X, Xiong X, Jin L, Ji W, Wang W. Pulmonary gas exchange impairment following tourniquet deflation: a prospective, single-blind clinical trial. Orthopedics. 2010 Jun 9;33(6):395. doi: 10.3928/01477447-20100429-15.
Matziolis G, Drahn T, Schroder JH, Krocker D, Tuischer J, Perka C. Endothelin-1 is secreted after total knee arthroplasty regardless of the use of a tourniquet. J Orthop Res. 2005 Mar;23(2):392-6. doi: 10.1016/j.orthres.2004.08.021.
Wang BQ, Kan YF, Yang QH. [The protective effect of the limb ischemia preconditioning on the hepatic injury related to NO/ET-1 system in rats]. Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2010 Aug;26(3):376-9. Chinese.
Shao D, Park JE, Wort SJ. The role of endothelin-1 in the pathogenesis of pulmonary arterial hypertension. Pharmacol Res. 2011 Jun;63(6):504-11. doi: 10.1016/j.phrs.2011.03.003. Epub 2011 Mar 16.
Luscher TF, Barton M. Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs. Circulation. 2000 Nov 7;102(19):2434-40. doi: 10.1161/01.cir.102.19.2434.
Tarwala R, Dorr LD, Gilbert PK, Wan Z, Long WT. Tourniquet use during cementation only during total knee arthroplasty: a randomized trial. Clin Orthop Relat Res. 2014 Jan;472(1):169-74. doi: 10.1007/s11999-013-3124-2.
Mittal R, Ko V, Adie S, Naylor J, Dave J, Dave C, Harris IA, Hackett D, Ngo D, Dietsch S. Tourniquet application only during cement fixation in total knee arthroplasty: a double-blind, randomized controlled trial. ANZ J Surg. 2012 Jun;82(6):428-33. doi: 10.1111/j.1445-2197.2012.06083.x. Epub 2012 May 10.
Chen S, Li J, Peng H, Zhou J, Fang H, Zheng H. The influence of a half-course tourniquet strategy on peri-operative blood loss and early functional recovery in primary total knee arthroplasty. Int Orthop. 2014 Feb;38(2):355-9. doi: 10.1007/s00264-013-2177-x. Epub 2013 Nov 21.
Hernandez-Castanos DM, Ponce VV, Gil F. Release of ischaemia prior to wound closure in total knee arthroplasty: a better method? Int Orthop. 2008 Oct;32(5):635-8. doi: 10.1007/s00264-007-0376-z. Epub 2007 May 15.
Wauke K, Nagashima M, Kato N, Ogawa R, Yoshino S. Comparative study between thromboembolism and total knee arthroplasty with or without tourniquet in rheumatoid arthritis patients. Arch Orthop Trauma Surg. 2002 Nov;122(8):442-6. doi: 10.1007/s00402-002-0404-9. Epub 2002 Apr 18.
Sapega AA, Heppenstall RB, Chance B, Park YS, Sokolow D. Optimizing tourniquet application and release times in extremity surgery. A biochemical and ultrastructural study. J Bone Joint Surg Am. 1985 Feb;67(2):303-14.
Kadoi Y, Ide M, Saito S, Shiga T, Ishizaki K, Goto F. Hyperventilation after tourniquet deflation prevents an increase in cerebral blood flow velocity. Can J Anaesth. 1999 Mar;46(3):259-64. doi: 10.1007/BF03012606.
Huang CH, Wang MJ, Chen TL, Huang HH, Hsu HW, Susetio L, Liu CC. Blood and central venous pressure responses after serial tourniquet deflation during bilateral total knee replacement. J Formos Med Assoc. 1996 Jun;95(6):496-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XYFY-2017-052
Identifier Type: -
Identifier Source: org_study_id