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Opioid Sparing General Venous Anesthesia With Magnesium Sulfate

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04005599
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Remifentanil group
  • Drug: Magnesium sulfate group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, controlled, randomized and double-blind clinical trial.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 :
Oct 1, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of using magnesium sulfate as analgesic of venous general anesthesia [Surgery time]

    Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.

Secondary Outcome Measures

  1. Anesthetic consumption. [During surgery]

    Consumption of propofol (mg) and cisatracurium.

  2. Neuromuscular blocker action [During surgery]

    Onset and offset of cisatracurium (minutes)

  3. Postoperative pain [Three days]

    Pain scores (verbal numerical scale from 0 to 10).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo São Paulo Brazil 01246-903

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Joaquim Vieira, Professor, University of Sao Paulo School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jul 2, 2019
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joaquim Edson Vieira, Associate professor, University of Sao Paulo General Hospital
Postoperative pain
opioid
Postoperative analgesia
Additional relevant MeSH terms:
Pain, Postoperative
Magnesium Sulfate
Remifentanil

Study Results

No Results Posted as of Mar 3, 2022