Opioid Sparing General Venous Anesthesia With Magnesium Sulfate

NCT ID: NCT04005599

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2022-01-06

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.

Conditions

Magnesium Sulfate; Postoperative Pain; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remifentanil group

Intravenous anesthesia with propofol and remifentanil

Group Type: ACTIVE_COMPARATOR

Remifentanil group

Intervention Type: DRUG

Venous general anesthesia with propofol and remifentanil.

Magnesium group

Intravenous anesthesia with propofol and magnesium sulfate

Group Type: EXPERIMENTAL

Magnesium sulfate group

Intervention Type: DRUG

Venous general anesthesia with propofol and magnesium sulfate

Interventions

Remifentanil group

Venous general anesthesia with propofol and remifentanil.

Intervention Type: DRUG

Magnesium sulfate group

Venous general anesthesia with propofol and magnesium sulfate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joaquim Edson Vieira

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquim Vieira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo School of Medicine

Locations

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

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CAAE 12614719.1.0000.0068

Identifier Type: -

Identifier Source: org_study_id