A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
Launched by STATE BUDGETARY HEALTHCARE INSTITUTION, NATIONAL MEDICAL SURGICAL CENTER N.A. N.I. PIROGOV, MINISTRY OF HEALTH OF RUSSIA · Apr 3, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- 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.
About State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry Of Health Of Russia
The National Medical Surgical Center named after N.I. Pirogov, a state budgetary healthcare institution under the Ministry of Health of Russia, is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes. With a strong emphasis on innovative surgical techniques and comprehensive healthcare solutions, the center operates at the forefront of clinical trials, facilitating the development and evaluation of new therapies and medical devices. Leveraging its state-of-the-art facilities and a team of expert clinicians, the institution fosters collaboration with national and international research entities to enhance the efficacy and safety of medical interventions, ultimately contributing to the advancement of public health in Russia and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Moscow, , Russian Federation
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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