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Opioid Sparing General Venous Anesthesia With Magnesium Sulfate

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ClinicalTrials.gov Identifier: NCT04005599
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Joaquim Edson Vieira, University of Sao Paulo General Hospital

Brief Summary:

Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.

This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.

The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.


Condition or disease Intervention/treatment Phase
Magnesium Sulfate Postoperative Pain Opioid Use Drug: Remifentanil group Drug: Magnesium sulfate group Not Applicable

Detailed Description:

Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.

This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.

The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.

Objectives The main objective of this project is to evaluate the feasibility of the use of magnesium sulfate in replacement of remifentanil as the main analgesic agent in total venous general anesthesia in patients submitted to post-bariatric dermolipectomy surgery.

The secondary objectives will be comparison of propofol consumption, time to onset of action, time of action and cisatracurium consumption between groups. We will evaluate pain scores in the immediate postoperative period and in the mornings and afternoons of the 3 days after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, controlled, randomized and double-blind clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The anesthesiologist in charge of randomization will number 40 opaque envelopes and insert a card in each with the corresponding information of the group (according to the lottery) and the medication to be administered. Another anesthesiologist in charge of preparing the blind solution alone will open the envelope. Both of these investigators, as well as the anesthesiologist providing anesthesia and the anesthesiologist in charge of data evaluation will not participate in any of the other steps of the trial. The patients will be blinded to their own treatment group.
Primary Purpose: Treatment
Official Title: Magnesium Sulfate in Substitution to Remifentanil. Intra-operative Analgesia Assessed by the Surgical Stress Index. Randomized and Blind Clinical Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil group
Intravenous anesthesia with propofol and remifentanil
Drug: Remifentanil group
Venous general anesthesia with propofol and remifentanil.

Experimental: Magnesium group
Intravenous anesthesia with propofol and magnesium sulfate
Drug: Magnesium sulfate group
Venous general anesthesia with propofol and magnesium sulfate




Primary Outcome Measures :
  1. Feasibility of using magnesium sulfate as analgesic of venous general anesthesia [ Time Frame: Surgery time ]
    Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.


Secondary Outcome Measures :
  1. Anesthetic consumption. [ Time Frame: During surgery ]
    Consumption of propofol (mg) and cisatracurium.

  2. Neuromuscular blocker action [ Time Frame: During surgery ]
    Onset and offset of cisatracurium (minutes)

  3. Postoperative pain [ Time Frame: Three days ]
    Pain scores (verbal numerical scale from 0 to 10).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 to 60 year-old
  • body mass index < 35 kg/m²
  • American Society of Anesthesiologists score < III
  • agreement to participate and sign the informed consent form.

Exclusion Criteria:

  • Allergy to any medications of the trial
  • neuromuscular diagnosed disorder
  • cardiac conduction blockade (atrioventricular block II or higher),
  • use of illicit drugs
  • use of calcium channel blockers
  • creatinine > 2 mg/dl.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005599


Contacts
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Contact: Joaquim Vieira, Professor 11995038702 joaquimev@usp.br
Contact: Sebastião Silva Filho, Physician 12991457764 sebasernesto@gmail.com

Locations
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Brazil
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Brazil, 01246-903
Contact: joaquim vieira, MD    55-11-30618716      
Contact: Sebastião Silva Filho, Physician    12991457764    sebasernesto@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Joaquim Vieira, Professor University of Sao Paulo School of Medicine
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Responsible Party: Joaquim Edson Vieira, Associate professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04005599    
Other Study ID Numbers: CAAE 12614719.1.0000.0068
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plan to made individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joaquim Edson Vieira, University of Sao Paulo General Hospital:
Postoperative pain
opioid
Postoperative analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents