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ENROLLING BY INVITATION
NCT05814991

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

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-05-29

Completion Date

2026-06-15

Last Updated

2023-05-31

Healthy Volunteers

No

Interventions

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.

Locations (1)

Pirogov National Medical and Surgical Center

Moscow, Russia