- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04946396
Virkninger af kontinuerlig dexmedetomidininfusion på systemisk mikrovaskulær funktion ved laparoskopisk kolecystektomi
Evaluering af virkningerne af kontinuerlig dexmedetomidininfusion på systemisk mikrovaskulær funktion hos patienter, der gennemgår laparoskopisk kolecystektomi: en prospektiv undersøgelse
The microcirculation represents the primary site of exchange of oxygen and nutrients for tissues, and the preservation of microcirculatory perfusion is essential for the maintenance of organ function. The microcirculation is extremely dynamic and may vary according to the individual's temperature, systemic blood pressure, the use of medications, during physical and mental activity, age and pathological processes. In this context, the development of portable microscopes for clinical use has made possible the non-invasive visualization of the microcirculation and tissue perfusion in patients undergoing several highly complex procedures in cardiology, including cardiac surgery with cardiopulmonary bypass, ECMO (Extracorporeal Membrane Oxygenation) and in critically ill patients in intensive care.
CytoCam, for example, is a handheld device that incorporates a darkfield incident light illumination system with a series of high-resolution lenses that project images to a computer dedicated to the system. Dexmedetomidine is a selective agonist of 2-adrenergic receptors in the central nervous system, whose administration results in a reduction in the activity of the sympathetic nervous system and a reduction in the systemic release of catecholamines. Its use in the perioperative period has several beneficial effects, such as reducing neuroendocrine and hemodynamic responses due to anesthesia and surgery, through induction of sedation and analgesia, in addition to reducing the consumption of opioids and anesthetics in general. Several recent studies report that the use of dexmedetomidine in the perioperative period reduces the incidence of postoperative complications, reduces the time on mechanical ventilation and attenuates the neuroendocrine response due to surgical trauma and extracorporeal circulation in patients undergoing cardiac surgery. However, the effects of dexmedetomidine on systemic microcirculation function during its use in anesthesia for elective surgical procedures of medium complexity are not yet known. In conclusion, the hypothesis of the present study is that continuous intravenous infusion of dexmedetomidine during balanced general anesthesia increases the microvascular perfusion flow rate in the sublingual mucosa, representing an increase in systemic microvascular perfusion.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
CytoCam, is a handheld device that incorporates a darkfield incident light illumination system with a series of high-resolution lenses that project images to a computer dedicated to the system. Dexmedetomidine is a selective agonist of 2-adrenergic receptors in the central nervous system, whose administration results in a reduction in the activity of the sympathetic nervous system and a reduction in the systemic release of catecholamines. Its use in the perioperative period has several beneficial effects, such as reducing neuroendocrine and hemodynamic responses due to anesthesia and surgery, through induction of sedation and analgesia, in addition to reducing the consumption of opioids and anesthetics in general. Several recent studies report that the use of dexmedetomidine in the perioperative period reduces the incidence of postoperative complications, reduces the time on mechanical ventilation and attenuates the neuroendocrine response due to surgical trauma and extracorporeal circulation in patients undergoing cardiac surgery. However, the effects of dexmedetomidine on systemic microcirculation function during its use in anesthesia for elective surgical procedures of medium complexity are not yet known. In conclusion, the hypothesis of the present study is that continuous intravenous infusion of dexmedetomidine during balanced general anesthesia increases the microvascular perfusion flow rate in the sublingual mucosa, representing an increase in systemic microvascular perfusion.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Rio de Janeiro, Brasilien, 22240006
- Eduardo Tibiriçá
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients of both sexes (age ≥ 18 and ≤ 75 years)
- Physical state ASA I or II according to the criteria of the American Association of Anesthesiology
- Planned surgery of cholecystectomy by videolaparoscopy
Exclusion Criteria:
- Patient's refusal to participate in the study
- Inflammation or infection in the sublingual mucosa
- Emergency surgery
- Grade III obesity (BMI ≥39.9 kg/m2)
- Pregnancy or lactation
- Autoimmune diseases, malignant neoplasms
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: dexmedetomidine intravenous infusion
Patients who will receive continuous intraoperative infusion of dexmedetomidine hydrochloride (0.5 µg/kg/h). |
Dexmedetomidine intravenous infusion during laparoscopic cholecystecthomy
Andre navne:
|
|
Sham-komparator: 0.9% saline solution intravenous infusion
Patients who will receive continuous infusion of 0.9% saline solution (sham group). |
0.9%sodium chloride intravenous infusion during laparoscopic cholecystecthomy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in microvascular flow index
Tidsramme: during surgery
|
sublingual microvascular density |
during surgery
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: EDUARDO TIBIRICA, MD, PhD, National Institute of Cardiology
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAAE 47593521.1.0000.5279
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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