MalocclusionNCT05814991
A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
An observational study of Malocclusion and Maxillofacial Injuries, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Malocclusion, Maxillofacial Injuries, Orthodontics
- What is being tested?
- Nitroglycerin solution and monitoring of cerebral oxygen saturation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 29 May 2023to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients undergoing bimaxillary osteotomy under general anesthesia
Who may be able to join
- Patients refered for bimaxillary osteotomy under general anesthesia with endotracheal intubation;
- Anesthesia risk classes (ASA) I and II;
- Written statement of informed consent.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Malocclusion, Maxillofacial Injuries, Orthodontics, Hemorrhage
- Being tested
- Nitroglycerin solution, monitoring of cerebral oxygen saturation
- 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
- Medical subject headings
- Malocclusion, Maxillofacial Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin solutionDrug
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.
monitoring of cerebral oxygen saturationDevice
Also called NIRS
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing bimaxillary osteotomy under general anesthesia | Not described Receives: Drug: Nitroglycerin solution; Device: monitoring of cerebral oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during osteotomy, up to 90 minutes
Secondary outcomes (7)
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
Measured: during osteotomy, up to 90 minutes
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:
MАP = Diastolic blood pressure + ((Systolic blood pressure - Diastolic blood pressure) / 3).
Measured: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
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.
Measured: 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
Total volume of blood loss during the time of surgery, calculated using direct volumetric measurement.
Measured: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
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.
Measured: within 3 days before operation, 2 days after surgery, 1 month after surgery
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.
Measured: at the start of the surgery, during controlled hypotension phase, immediately after extubation
Change in Troponin I concentration
The test can be used to aid in diagnosing myocardial infarction.
Measured: at the start of the surgery, during controlled hypotension phase, immediately after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start29 May 2023
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814991
- Sponsor's protocol ID
- NMSC-01-23
- Status last verified
- May 2023
- First submitted
- 3 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21195531Sugahara 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.
PubMed 35212834Salma 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.
PubMed 28466191Ha 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.
PubMed 24604576Ferri 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.
PubMed 31495753Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.
PubMed 17488147Ettinger 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.
PubMed 26047710Lin 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.
PubMed 27542543Varol 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.
PubMed 19913434Rodrigo C. Induced hypotension during anesthesia with special reference to orthognathic surgery. Anesth Prog. 1995;42(2):41-58.
PubMed 8934953Wesselink 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.
PubMed 30236233Mathis 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.
PubMed 31794513Gregory 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.
PubMed 33177322Farah 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.
PubMed 18940490Rhee 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.
PubMed 33628100
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05814991
- Acronym / sponsor ID
- NMSC-01-23
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing bimaxillary osteotomy under general anesthesia | – | Drug: Nitroglycerin solution, Device: monitoring of cerebral oxygen saturation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients undergoing bimaxillary osteotomy under general anesthesia
Key inclusion criteria (3 listed)
- Patients refered for bimaxillary osteotomy under general anesthesia with endotracheal intubation;
- Anesthesia risk classes (ASA) I and II;
- Written statement of informed consent.
Key exclusion criteria (14 listed)
- Hypertension as a symptom of hypertensive heart disease or endocrine dysfunction;
- Patients receiving antihypertensive drugs;
- Patients receiving anticoagulant therapy;
- Ischemic heart disease;
- Cerebrovascular insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin solutionControlled 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. | Drug | Patients undergoing bimaxillary osteotomy under general anesthesia |
| monitoring of cerebral oxygen saturationAlso: NIRSNIRS-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. | Device | Patients undergoing bimaxillary osteotomy under general anesthesia |
Primary outcome
Visibility of surgical site
Time frame: during osteotomy, up to 90 minutes
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.
7 secondary outcomes
Proportion of patients with cerebral desaturation
Time frame: during osteotomy, up to 90 minutes
changes in the values of mean arterial pressure
Time frame: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
Changes in neuron-specific enolase (NSE) concentration
Time frame: 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
Time frame: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
Cognitive status change
Time frame: within 3 days before operation, 2 days after surgery, 1 month after surgery
Changes in cystatin C concentration
Time frame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
Change in Troponin I concentration
Time frame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 21195531Pineiro-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.
- Background: PubMed 35212834Sugahara 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.
- Background: PubMed 28466191Salma 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.
- Background: PubMed 24604576Ha 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.
- Background: PubMed 31495753Ferri 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.
- Background: PubMed 17488147Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.
- Background: PubMed 26047710Ettinger 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.
- Background: PubMed 27542543Lin 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.
- Background: PubMed 19913434Varol 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.
- Background: PubMed 8934953Rodrigo C. Induced hypotension during anesthesia with special reference to orthognathic surgery. Anesth Prog. 1995;42(2):41-58.
- Background: PubMed 30236233Wesselink 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.
- Background: PubMed 31794513Mathis 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.
- Individual participant dataSharing planned: Yes
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Maxillofacial Injuries, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility of surgical site (time frame: during osteotomy, up to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814991, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.