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

NCT04946396 | Completed

• 1 other identifier: CAAE 47593521.1.0000.5279
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery

Keywords

dexmedetomidine; microcirculation; general anesthesia; central alpha-2 agonists; tissue perfusion

Outcome Measures

Primary Outcomes (1)

• change in microvascular flow index

  sublingual microvascular density

  during surgery

Study Arms (2)

dexmedetomidine intravenous infusion

EXPERIMENTAL

Patients who will receive continuous intraoperative infusion of dexmedetomidine hydrochloride (0.5 µg/kg/h).

Drug: dexmedetomidine intravenous infusion

0.9% saline solution intravenous infusion

SHAM COMPARATOR

Patients who will receive continuous infusion of 0.9% saline solution (sham group).

Drug: 0.9%sodium chloride

Interventions

0.9%sodium chloride DRUG

0.9%sodium chloride intravenous infusion during laparoscopic cholecystecthomy

0.9% saline solution intravenous infusion

dexmedetomidine intravenous infusion DRUG

Dexmedetomidine intravenous infusion during laparoscopic cholecystecthomy

dexmedetomidine intravenous infusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• EDUARDO TIBIRICA, MD, PhD

  National Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Patients will be randomized into two groups of 35 patients each: 1) patients who will receive continuous intraoperative infusion of dexmedetomidine hydrochloride (0.5 µg/kg/h) (DEX group) or 2) control group, patients who will receive continuous infusion of 0.9% saline solution (CONT group).

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: April 1, 2022
• Primary Completion: May 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

BR (1)