A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery

NCT05814991 | Enrolling By Invitation

• 1 other identifier: NMSC-01-23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion; Maxillofacial Injuries; Orthodontics; Hemorrhage

Keywords

nitroglycerin; the quality of visualization of the operating field; Near-infrared Spectroscopy (NIRS); cerebral oximetry; regional cerebral oxygen saturation (rSO2); Le Fort; I; controlled hypotension anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of patients with cerebral desaturation

  during osteotomy, up to 90 minutes

• changes in the values of mean arterial pressure

  during the whole surgery (from start to finish - the timing stated in the surgery protocol)

• Changes in neuron-specific enolase (NSE) concentration

  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

• Intraoperative blood loss

  during the whole surgery (from start to finish - the timing stated in the surgery protocol)

• Cognitive status change

  within 3 days before operation, 2 days after surgery, 1 month after surgery

Study Arms (1)

Patients undergoing bimaxillary osteotomy under general anesthesia

Drug: Nitroglycerin solution; Device: monitoring of cerebral oxygen saturation

Interventions

Nitroglycerin solution DRUG

Controlled hypotension will be induced (intravenous administration of nitroglycerin 2-10 µg/kg/min) 15 minutes prior to the start of mucosal detachment, and will be sustained for the osteotomy stage.

Patients undergoing bimaxillary osteotomy under general anesthesia

monitoring of cerebral oxygen saturation DEVICE

NIRS-based monitoring of rSO2 has unique advantages: directly or indirectly detecting physiological changes and metabolic processes, it is easy to realize, and involves simple procedures.

Also known as: NIRS

Patients undergoing bimaxillary osteotomy under general anesthesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing bimaxillary osteotomy under general anesthesia

You may qualify if:

• Patients refered for bimaxillary osteotomy under general anesthesia with endotracheal intubation;
• Anesthesia risk classes (ASA) I and II;
• Written statement of informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

Location

Related Publications (16)

• 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.

  PMID: 21195531 BACKGROUND

• 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.

  PMID: 35212834 BACKGROUND

• 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.

  PMID: 28466191 BACKGROUND

• 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.

  PMID: 24604576 BACKGROUND

• 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.

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• Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.

  PMID: 17488147 BACKGROUND

• 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.

  PMID: 26047710 BACKGROUND

• 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.

  PMID: 27542543 BACKGROUND

• 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.

  PMID: 19913434 BACKGROUND

• Rodrigo C. Induced hypotension during anesthesia with special reference to orthognathic surgery. Anesth Prog. 1995;42(2):41-58.

  PMID: 8934953 BACKGROUND

• 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.

  PMID: 30236233 BACKGROUND

• 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.

  PMID: 31794513 BACKGROUND

• 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.

  PMID: 33177322 BACKGROUND

• 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.

  PMID: 18940490 BACKGROUND

• 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.

  PMID: 33628100 BACKGROUND

• 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.

  PMID: 33079868 BACKGROUND

MeSH Terms

Conditions

Malocclusion; Maxillofacial Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: May 29, 2023
• Primary Completion: January 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of the study
• Access Criteria: upon the request

Locations

RU (1)