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Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies

Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05489900
Enrollment
52
Registered
2022-08-05
Start date
2022-04-01
Completion date
2022-10-31
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological Effects of Drugs

Keywords

Immunomodulation, Dexmedetomidine, videolaparoscopic cholecystectomy

Brief summary

Trauma triggers a tissue response involving the central nervous system, the hypothalamic-pituitary-adrenal axis and the immune system. There are many surgical and anesthetic factors that affect the response to trauma, and the control of the inflammatory factor is considered the most important. (KÜÇÜKEBE, O.B. ET AL, 2017). Dexmedetomidine is a specific α2-adrenergic agonist. By direct action on the sympathetic nervous system, α2-adrenergic agonists can exert beneficial effects on the immune system through neuroimmune interactions. Its administration can induce an anti-inflammatory response due to different central (increase parasympathetic tone, promoting control of the inflammatory condition) and peripheral effects (stimulating innate immunity). (MILLER, 2015). This study aims to evaluate the effect of dexmedetomidine administration in association with general anesthesia in a medium-sized surgical model, videolaparoscopic cholecystectomy.

Detailed description

The present study is a randomized, single-blind, prospective clinical trial. Its objective is to evaluate the possible qualitative changes in organic function and in the systemic inflammatory response when using dexmedetomidine associated with general anesthesia for laparoscopic cholecystectomy surgeries. The study was designed and executed according to the surgical routine of the Hospital Universitário Gaffré e Guinle - RJ. The anesthesiology service is recognized by the Ministry of Education and the Brazilian Society of Anesthesiology. Participant registration data will be replaced by codes for the preservation of personal information. The following were used in the elaboration of the study: 1) Selection of ASA I and II patients listed for elective procedures and standardization of the anesthetic technique. 2) A standardized data collection system in a specific form and fed with the residents with adequate supervision; 3) procedures converted into open surgery were excluded, since they imply an increase in surgical trauma and absence of pneumoperitoneum perfusion-reperfusion syndrome;4) Two groups with similar characteristics were used and the only difference will be the administration or not of dexmedetomidine in the procedure under study;5) Study with single blinding: the patient, also called the object of study, does not know which group he belongs to. The investigator does. Continuous infusions of dexmedetomidine or 0.9% saline (placebo) were used. Dexmedetomidine was used in the intervention group as follows: beginning in anesthetic induction after obtaining venous access at 1mcg/kg/h for 20 minutes, followed by 0.2 - 0.5 mcg/kg/h until surgery was completed. The placebo group will receive 0.9% saline infusion at the same rates as the intervention group. Venous blood samples were collected at three times (T1, T2 and T3): Before anesthetic induction with collection in the preoperative environment on the day of surgery or during venoclysis before anesthetic induction (sample 1, T1); 6 hours after starting orifice closure and completion of drug or placebo infusion (sample 2, T2); and the last blood sample will be collected by me on the morning after the postoperative period, close to hospital discharge (sample 3, T3). Will be measured in all venous blood samples: IL-6, cortisol, CRP and glycemia (dosing techniques -chemiluminescence or ELISA).

Interventions

DRUGDexmedetomidine Hydrochloride

Dexmedetomidine is a specific and potent α2-adrenergic agonist. By acting directly on the sympathetic nervous system, they can exert beneficial effects on the immune system through neuroimmune interactions. Its administration can induce an anti-inflammatory response due to different central (increase parasympathetic tone, promoting control of the inflammatory condition) and peripheral effects (stimulating innate immunity).(MILLER, 2015). Venous blood samples were collected at three times (T1, T2 and T3): Before anesthetic induction with collection in the preoperative environment on the day of surgery or during venoclysis before anesthetic induction (sample 1, T1); 6 hours after starting orifice closure and completion of drug or placebo infusion (sample 2, T2); and the last blood sample will be collected by me on the morning after the postoperative period, close to hospital discharge - 24h (sample 3, T3).

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Patients were randomly divided into two groups using the sequential distribution procedure of Pocock and Simon to balance the amount of sex and age group of patients between the groups. Participants' registration data were replaced by codes for the preservation of personal information.

Intervention model description

Patients with Physical Health Status Classification 1 and 2, submitted to elective videolaparoscopic cholecystectomy surgery and previously signed the Free and Informed Consent Form. Continuous infusions of dexmedetomidine or 0.9% saline (placebo) were used in 52 patients. Dexmedetomidine was infused in the intervention group (26 patients) as follows: beginning of anesthetic induction after obtaining venous access at 1mcg/kg/h for 20 minutes, followed by 0.2 - 0.5 mcg/kg/h until the closure of the surgery. The placebo group (26 patients) received 0.9% saline infusion at the same rates as the intervention group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients ASA I and II * Elective Videolaparoscopic Cholecystectomy Surgery * Patients who signed the Free and Informed Consent Form

Exclusion criteria

* Patients ASA \> II * Conversion to open surgery * Emergency Surgeries

Design outcomes

Primary

MeasureTime frameDescription
Attenuation of the inflammatory response to traumaUp to 24 hoursAttenuation of the inflammatory response to trauma, with a reduction in the levels of Interleukin 6, C-Reactive Protein and cortisol, through a decrease of at least 5% in the values of the samples of the intervention group.

Secondary

MeasureTime frameDescription
Physiological functions more preserved than the control groupUp to 24 hoursPostoperative analgesic and antiemetic effects, early return of physiological functions, verified by a reduction of at least 10% in pain scores; capnography greater than 40 mmHg; respiratory rate greater than 12 bpm and tidal volume of 6 to 8 mL/kg (absence of pathological changes in pulmonary function).

Countries

Brazil

Contacts

Primary ContactGustavo Silva, MD
gustavo.silva@unirio.br+55 32999006102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026