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

May 30, 2023 updated by: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 105203
        • Pirogov National Medical and Surgical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing bimaxillary osteotomy under general anesthesia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing bimaxillary osteotomy under general anesthesia
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.
Other Names:
  • NIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during osteotomy, up to 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with cerebral desaturation
Time Frame: during osteotomy, up to 90 minutes
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
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 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).
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
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
Intraoperative blood loss
Time Frame: during the whole surgery (from start to finish - the timing stated in the surgery protocol)
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)
Cognitive status change
Time Frame: within 3 days before operation, 2 days after surgery, 1 month after surgery
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
Changes in cystatin C concentration
Time Frame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
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
Change in Troponin I concentration
Time Frame: at the start of the surgery, during controlled hypotension phase, immediately after extubation
The test can be used to aid in diagnosing myocardial infarction.
at the start of the surgery, during controlled hypotension phase, immediately after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMSC-01-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

6 months after completion of the study

IPD Sharing Access Criteria

upon the request

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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