Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04005599 |
| Other study ID # |
CAAE 12614719.1.0000.0068 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 3, 2019 |
| Est. completion date |
January 6, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
