Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Magnesium Sulfate
- Opioid Use
- Postoperative Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 18 years
- Gender
- Both males and females
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 i...
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.
Tracking Information
- NCT #
- NCT04005599
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joaquim Vieira, Professor University of Sao Paulo School of Medicine
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