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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05814991
• Other study ID #: NMSC-01-23
• Status: Enrolling by invitation
• Start date: May 29, 2023
• Est. completion date: June 15, 2026

Study information

• Verified date: May 2023
• Source: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

100 patients undergoing bimaxillary osteotomy under general anesthesia will be included into this prospective cohort study.

There will be two episodes of controlled hypotension for upper and lower jaw respectively. Hypotension will be induced and sustained according to the same procedure as described here. 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. The surgeon will evaluate the surgical field quality (in terms of bleeding) according to Modena Bleeding Score (MBS), with scores 1-2 being satisfactory to proceed with the osteotomy. The following arterial pressure correction (proceeding with controlled hypotension or returning to normotension) will depend on the bleeding in the surgical field and the monitoring of cerebral oxygen saturation carried out using near-infrared spectroscopy (NIRS) . The lowest targeted arterial pressure in order to have a clear surgical field will be 55 mmHg. However when the cerebral oxygen saturation decreases by 20% compared with the baseline at any arterial pressure level intervention would be carried out by Norepinephrine (intravenous, individual dosage for each patient - as judged by the anesthesiologist). Arterial blood samples will be taken at 3 time points (at the start of the surgery, during controlled hypotension phase, after extubation) for arterial gas analysis. Two blood samples will be taken to measure (prior to surgery and immediately after surgery) neuron-specific enolase (NSE), cystatin c and troponin I levels. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded. Cognitive function will be evaluated within 3 days before surgery and 2 days and 1 month after surgery.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hemorrhage
• Malocclusion
• Maxillofacial Injuries
• Orthodontics

Intervention

Drug:
• Nitroglycerin solution
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.

Device:
• monitoring of cerebral oxygen saturation
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.

Locations

Country	Name	City	State
Russian Federation	Pirogov National Medical and Surgical Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (16)

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

Outcome

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