Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
Primary Purpose
Magnesium Sulfate, Postoperative Pain, Opioid Use
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Remifentanil group
Magnesium sulfate group
Sponsored by

About this trial
This is an interventional treatment trial for Magnesium Sulfate focused on measuring Postoperative pain, opioid, Postoperative analgesia
Eligibility 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.
Sites / Locations
- Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Remifentanil group
Magnesium group
Arm Description
Intravenous anesthesia with propofol and remifentanil
Intravenous anesthesia with propofol and magnesium sulfate
Outcomes
Primary Outcome Measures
Feasibility of using magnesium sulfate as analgesic of venous general anesthesia
Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.
Secondary Outcome Measures
Anesthetic consumption.
Consumption of propofol (mg) and cisatracurium.
Neuromuscular blocker action
Onset and offset of cisatracurium (minutes)
Postoperative pain
Pain scores (verbal numerical scale from 0 to 10).
Full Information
NCT ID
NCT04005599
First Posted
June 25, 2019
Last Updated
November 3, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04005599
Brief Title
Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
Official Title
Magnesium Sulfate in Substitution to Remifentanil. Intra-operative Analgesia Assessed by the Surgical Stress Index. Randomized and Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnesium Sulfate, Postoperative Pain, Opioid Use
Keywords
Postoperative pain, opioid, Postoperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, randomized and double-blind clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil group
Arm Type
Active Comparator
Arm Description
Intravenous anesthesia with propofol and remifentanil
Arm Title
Magnesium group
Arm Type
Experimental
Arm Description
Intravenous anesthesia with propofol and magnesium sulfate
Intervention Type
Drug
Intervention Name(s)
Remifentanil group
Intervention Description
Venous general anesthesia with propofol and remifentanil.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate group
Intervention Description
Venous general anesthesia with propofol and magnesium sulfate
Primary Outcome Measure Information:
Title
Feasibility of using magnesium sulfate as analgesic of venous general anesthesia
Description
Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.
Time Frame
Surgery time
Secondary Outcome Measure Information:
Title
Anesthetic consumption.
Description
Consumption of propofol (mg) and cisatracurium.
Time Frame
During surgery
Title
Neuromuscular blocker action
Description
Onset and offset of cisatracurium (minutes)
Time Frame
During surgery
Title
Postoperative pain
Description
Pain scores (verbal numerical scale from 0 to 10).
Time Frame
Three days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim Vieira, Professor
Organizational Affiliation
University of Sao Paulo School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have no plan to made individual participant data available to other researchers.
Learn more about this trial
Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
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