- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05489900
Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Gustavo Silva, MD
- Phone Number: +55 32999006102
- Email: gustavo.silva@unirio.br
Study Locations
-
-
-
Rio De Janeiro, Brazil, 20270-004
- Recruiting
- University Hospital Gaffree and Guinle
-
Contact:
- Gustavo Silva, MD
- Phone Number: +55 32 999006102
- Email: gustavo.silva@unirio.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 0.9% Saline Infusion
The placebo group will receive 0.9% saline infusion at the same rates as the intervention group.
|
|
EXPERIMENTAL: Dexmedetomidine Infusion
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.
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attenuation of the inflammatory response to trauma
Time Frame: Up to 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological functions more preserved than the control group
Time Frame: Up to 24 hours
|
Postoperative 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).
|
Up to 24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gustavo Silva, MD, UNIRIO - FEDERAL UNIVERSITY OF THE STATE OF RIO DE JANEIRO
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 50311621.0.0000.5258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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