Hemorrhage Clinical Trial
Official title:
A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
It is very important to decrease the bleeding during bimaxillary osteotomy in order to increase the visibility of the surgical site. Our primary goal is to investigate the predictive value of pre- and perioperative factors, including controlled hypotension, on visibility of surgical site during bimaxillary osteotomy.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | June 15, 2026 |
Est. primary completion date | January 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients refered for bimaxillary osteotomy under general anesthesia with endotracheal intubation; - Anesthesia risk classes (ASA) I and II; - Written statement of informed consent. Exclusion Criteria: - Hypertension as a symptom of hypertensive heart disease or endocrine dysfunction; - Patients receiving antihypertensive drugs; - Patients receiving anticoagulant therapy; - Ischemic heart disease; - Cerebrovascular insufficiency; - Severe hypovolemia; - Anemia; - BMI 30 kg/m2 and higher; - Connective tissue disorders; - Pregnancy; - Participation in other clinical studies; - Recent history of substance abuse (recreational drugs, alcohol); - Allergies to drugs used in the study; - Anxiety requiring psychiatrist supervision and pharmacological therapy. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Pirogov National Medical and Surgical Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia |
Russian Federation,
Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007. — View Citation
Ettinger KS, Yildirim Y, Weingarten TN, Van Ess JM, Viozzi CF, Arce K. Hypotensive Anesthesia Is Associated With Shortened Length of Hospital Stay Following Orthognathic Surgery. J Oral Maxillofac Surg. 2016 Jan;74(1):130-8. doi: 10.1016/j.joms.2015.05.025. Epub 2015 May 28. — View Citation
Farah GJ, de Moraes M, Filho LI, Pavan AJ, Camarini ET, Previdelli IT, Coelho L. Induced hypotension in orthognathic surgery: a comparative study of 2 pharmacological protocols. J Oral Maxillofac Surg. 2008 Nov;66(11):2261-9. doi: 10.1016/j.joms.2008.06.045. — View Citation
Ferri J, Druelle C, Schlund M, Bricout N, Nicot R. Complications in orthognathic surgery: A retrospective study of 5025 cases. Int Orthod. 2019 Dec;17(4):789-798. doi: 10.1016/j.ortho.2019.08.016. Epub 2019 Sep 5. — View Citation
Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250. — View Citation
Ha TN, van Renen RG, Ludbrook GL, Valentine R, Ou J, Wormald PJ. The relationship between hypotension, cerebral flow, and the surgical field during endoscopic sinus surgery. Laryngoscope. 2014 Oct;124(10):2224-30. doi: 10.1002/lary.24664. Epub 2014 Apr 22. — View Citation
Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25. — View Citation
Mathis MR, Naik BI, Freundlich RE, Shanks AM, Heung M, Kim M, Burns ML, Colquhoun DA, Rangrass G, Janda A, Engoren MC, Saager L, Tremper KK, Kheterpal S, Aziz MF, Coffman T, Durieux ME, Levy WJ, Schonberger RB, Soto R, Wilczak J, Berman MF, Berris J, Biggs DA, Coles P, Craft RM, Cummings KC, Ellis TA 2nd, Fleishut PM, Helsten DL, Jameson LC, van Klei WA, Kooij F, LaGorio J, Lins S, Miller SA, Molina S, Nair B, Paganelli WC, Peterson W, Tom S, Wanderer JP, Wedeven C; Multicenter Perioperative Outcomes Group Investigators. Preoperative Risk and the Association between Hypotension and Postoperative Acute Kidney Injury. Anesthesiology. 2020 Mar;132(3):461-475. doi: 10.1097/ALN.0000000000003063. Erratum In: Anesthesiology. 2020 Jan 6;: — View Citation
Pineiro-Aguilar A, Somoza-Martin M, Gandara-Rey JM, Garcia-Garcia A. Blood loss in orthognathic surgery: a systematic review. J Oral Maxillofac Surg. 2011 Mar;69(3):885-92. doi: 10.1016/j.joms.2010.07.019. Epub 2010 Dec 31. — View Citation
Rhee SH, An JS, Seo KS, Karm MH. Predictors of Red Blood Cell Transfusion in Bimaxillary Orthognathic Surgery: A Retrospective Study. Int J Med Sci. 2021 Jan 29;18(6):1432-1441. doi: 10.7150/ijms.55567. eCollection 2021. — View Citation
Rodrigo C. Induced hypotension during anesthesia with special reference to orthognathic surgery. Anesth Prog. 1995;42(2):41-58. — View Citation
Salma RG, Al-Shammari FM, Al-Garni BA, Al-Qarzaee MA. Operative time, blood loss, hemoglobin drop, blood transfusion, and hospital stay in orthognathic surgery. Oral Maxillofac Surg. 2017 Jun;21(2):259-266. doi: 10.1007/s10006-017-0626-1. Epub 2017 May 2. — View Citation
Sugahara K, Koyama Y, Koyachi M, Watanabe A, Kasahara K, Takano M, Katakura A. A clinico-statistical study of factors associated with intraoperative bleeding in orthognathic surgery. Maxillofac Plast Reconstr Surg. 2022 Feb 25;44(1):7. doi: 10.1186/s40902-022-00336-8. — View Citation
Thiele RH, Shaw AD, Bartels K, Brown CH 4th, Grocott H, Heringlake M, Gan TJ, Miller TE, McEvoy MD; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Cerebral Near-Infrared Spectroscopy. Anesth Analg. 2020 Nov;131(5):1444-1455. doi: 10.1213/ANE.0000000000005081. — View Citation
Varol A, Basa S, Ozturk S. The role of controlled hypotension upon transfusion requirement during maxillary downfracture in double-jaw surgery. J Craniomaxillofac Surg. 2010 Jul;38(5):345-9. doi: 10.1016/j.jcms.2009.10.012. Epub 2009 Nov 12. — View Citation
Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visibility of surgical site | Surgical site will be rated according to Modena Bleeding Score (MBS) by the same surgeon in terms of bleeding during osteotomy. The MBS goes from Grade 1 - no bleeding to Grade 5 - bleeding that prevents every surgical procedure except those dedicated to bleeding control. | during osteotomy, up to 90 minutes | |
Secondary | Proportion of patients with cerebral desaturation | Proportion of patients with decrease in cerebral oxygen saturation decreased by 20% compared with the baseline for 300 seconds without improvement | during osteotomy, up to 90 minutes | |
Secondary | changes in the values of mean arterial pressure | Changes in mean arterial pressure (MAP) values before and during controlled hypotension phase will be registered.
MAP calculated as follows: M?P = Diastolic blood pressure + ((Systolic blood pressure - Diastolic blood pressure) / 3). |
during the whole surgery (from start to finish - the timing stated in the surgery protocol) | |
Secondary | Changes in neuron-specific enolase (NSE) concentration | NSE is released from neurons during injury and it's high blood concentration is associated with ischemic brain injury. Level of NSE will be measured in blood samples taken during surgery. Increase of NSE level suggests brain ischemia. | 3 time-points during the surgery - immediately after anesthesia induction, at the time of controlled hypotension (5 minutes after induction of controlled hypotension, i.e. nitroglycerin i.v. administration), immediately after extubation | |
Secondary | Intraoperative blood loss | Total volume of blood loss during the time of surgery, calculated using direct volumetric measurement. | during the whole surgery (from start to finish - the timing stated in the surgery protocol) | |
Secondary | Cognitive status change | Cognitive function will be evaluated by means of Mini Mental State Examination (MMSE), which is a 30-point test, validated and commonly used to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. | within 3 days before operation, 2 days after surgery, 1 month after surgery | |
Secondary | Changes in cystatin C concentration | Cystatin C is a well investigated biomarker with clear advantages over serum creatinine in patients with extremes in muscle mass, weight, age, and other areas where estimating equations using creatinine have well documented limitations. Increase of cystatin C level suggests kidney impairment. | at the start of the surgery, during controlled hypotension phase, immediately after extubation | |
Secondary | Change in Troponin I concentration | The test can be used to aid in diagnosing myocardial infarction. | at the start of the surgery, during controlled hypotension phase, immediately after extubation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02815670 -
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
|
Phase 3 | |
Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
Completed |
NCT02569606 -
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
|
||
Recruiting |
NCT02446730 -
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
Completed |
NCT01955720 -
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
|
Phase 1 | |
Completed |
NCT01935427 -
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
|
N/A | |
Recruiting |
NCT01709786 -
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01191554 -
Dose-ranging Study of Tranexamic Acid in Valve Surgery
|
N/A | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01085006 -
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
|
Phase 1/Phase 2 | |
Completed |
NCT00700141 -
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
|
N/A | |
Completed |
NCT00375466 -
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
|
N/A | |
Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
Completed |
NCT00147420 -
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|
N/A | |
Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
Completed |
NCT03273322 -
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05672407 -
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
|
Phase 4 |