Effects of Continuous Dexmedetomidine Infusion on Systemic Microvascular Function in Laparoscopic Cholecystecthomy

Evaluation of the Effects of Continuous Dexmedetomidine Infusion on Systemic Microvascular Function in Patients Undergoing Laparoscopic Cholecystecthomy: a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Drug: dexmedetomidine intravenous infusion; Drug: 0.9%sodium chloride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240006
    • Eduardo Tibiriçá

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients of both sexes (age ≥ 18 and ≤ 60 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine intravenous infusion; Patients who will receive continuous intraoperative infusion of dexmedetomidine hydrochloride (0.5 µg/kg/h).	Drug: dexmedetomidine intravenous infusion; Dexmedetomidine intravenous infusion during laparoscopic cholecystecthomy
Sham Comparator: 0.9% saline solution intravenous infusion; Patients who will receive continuous infusion of 0.9% saline solution (sham group).	Drug: 0.9%sodium chloride; 0.9%sodium chloride intravenous infusion during laparoscopic cholecystecthomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in microvascular flow index	sublingual microvascular density	during surgery

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil
• Investigators: Principal Investigator: EDUARDO TIBIRICA, MD, PhD, National Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: general anesthesia; dexmedetomidine; microcirculation; tissue perfusion; central alpha-2 agonists
• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: CAAE 47593521.1.0000.5279

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No