UnknownNot Applicable

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

Russia100 participantsStarted 2023-05-29

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visibility of surgical site

Timeframe: during osteotomy, up to 90 minutes

Trial details

NCT IDNCT05814991

SponsorState Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Malocclusion trials