Clinical trial NCT05814991: A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
Official title: A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing bimaxillary osteotomy under general anesthesia

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.

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.

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.

Primary outcomes:
measure: Visibility of surgical site
timeFrame: during osteotomy, up to 90 minutes
Secondary outcomes:
measure: Proportion of patients with cerebral desaturation
timeFrame: during osteotomy, up to 90 minutes
measure: changes in the values of mean arterial pressure
timeFrame: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
measure: Changes in neuron-specific enolase (NSE) concentration
timeFrame: 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
measure: Intraoperative blood loss
timeFrame: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
measure: Cognitive status change
timeFrame: within 3 days before operation, 2 days after surgery, 1 month after surgery
measure: Changes in cystatin C concentration
timeFrame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
measure: Change in Troponin I concentration
timeFrame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Medical and Surgical Center
Study officials:
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