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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

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Anesthetic consumption. [ Time Frame: During surgery ]
    Consumption of propofol (mg) and cisatracurium.
  • Neuromuscular blocker action [ Time Frame: During surgery ]
    Onset and offset of cisatracurium (minutes)
  • Postoperative pain [ Time Frame: Three days ]
    Pain scores (verbal numerical scale from 0 to 10).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
Official Title  ICMJE Magnesium Sulfate in Substitution to Remifentanil. Intra-operative Analgesia Assessed by the Surgical Stress Index. Randomized and Blind Clinical Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Magnesium Sulfate
  • Postoperative Pain
  • Opioid Use
Intervention  ICMJE
  • Drug: Remifentanil group
    Venous general anesthesia with propofol and remifentanil.
  • Drug: Magnesium sulfate group
    Venous general anesthesia with propofol and magnesium sulfate
Study Arms  ICMJE
  • Active Comparator: Remifentanil group
    Intravenous anesthesia with propofol and remifentanil
    Intervention: Drug: Remifentanil group
  • Experimental: Magnesium group
    Intravenous anesthesia with propofol and magnesium sulfate
    Intervention: Drug: Magnesium sulfate group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 18 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joaquim Vieira, Professor 11995038702 joaquimev@usp.br
Contact: Sebastião Silva Filho, Physician 12991457764 sebasernesto@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005599
Other Study ID Numbers  ICMJE CAAE 12614719.1.0000.0068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We have no plan to made individual participant data available to other researchers.
Responsible Party Joaquim Edson Vieira, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joaquim Vieira, Professor University of Sao Paulo School of Medicine
PRS Account University of Sao Paulo General Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP