Opioid Sparing General Venous Anesthesia With Magnesium Sulfate

NCT04005599 | Completed

• 1 other identifier: CAAE 12614719.1.0000.0068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnesium Sulfate; Postoperative Pain; Opioid Use

Keywords

Postoperative pain; opioid; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Surgery time

Secondary Outcomes (3)

• Anesthetic consumption.

  During surgery

• Neuromuscular blocker action

  During surgery

• Postoperative pain

  Three days

Study Arms (2)

Remifentanil group

ACTIVE COMPARATOR

Intravenous anesthesia with propofol and remifentanil

Drug: Remifentanil group

Magnesium group

EXPERIMENTAL

Intravenous anesthesia with propofol and magnesium sulfate

Drug: Magnesium sulfate group

Interventions

Remifentanil group DRUG

Venous general anesthesia with propofol and remifentanil.

Remifentanil group

Magnesium sulfate group DRUG

Venous general anesthesia with propofol and magnesium sulfate

Magnesium group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Joaquim Vieira, Professor

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Prospective, controlled, randomized and double-blind clinical trial.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 2, 2019
• Study Start: June 3, 2019
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)