Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies

NCT05489900 | Unknown Phase 3 DMC

• 1 other identifier: 50311621.0.0000.5258
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Effects of Drugs

Keywords

Immunomodulation; Dexmedetomidine; videolaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Attenuation of the inflammatory response to trauma

  Attenuation 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.

  Up to 24 hours

Secondary Outcomes (1)

• Physiological functions more preserved than the control group

  Up to 24 hours

Study Arms (2)

0.9% Saline Infusion

NO INTERVENTION

The placebo group will receive 0.9% saline infusion at the same rates as the intervention group.

Dexmedetomidine Infusion

EXPERIMENTAL

Dexmedetomidine will be 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 the end of the surgery.

Drug: Dexmedetomidine Hydrochloride

Interventions

Dexmedetomidine Hydrochloride DRUG

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).

Dexmedetomidine Infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

University Hospital Gaffree and Guinle

Rio de Janeiro, 20270-004, Brazil

RECRUITING

Related Publications (1)

• Silva GN, Brandao VG, Fiorelli R, Perez MV, Mello CR, Negrini D, Levandrowski KU, Martinelli RB, Reis TPDAD. Outcomes of dexmedetomidine as adjuvant drug in patients undergoing videolaparoscopic cholecystectomy: A randomized and prospective clinical trial. Int J Immunopathol Pharmacol. 2023 Jan-Dec;37:3946320231196977. doi: 10.1177/03946320231196977.

  PMID: 37604516 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gustavo Silva, MD

  UNIRIO - FEDERAL UNIVERSITY OF THE STATE OF RIO DE JANEIRO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Silva, MD

CONTACT

+55 32999006102; gustavo.silva@unirio.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: April 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)