Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04058106 |
| Other study ID # |
3-2019-0142 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 19, 2019 |
| Est. completion date |
July 15, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Gangnam Severance Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Previous study reported that propofol binded to glutamate receptors in the hypothalamus and
inhibits AVP release mediated by endogenous γ-aminobutyric acid, as well as directly inhibits
the regulated calcium currents leading to normal neuronal depolarization and AVP release.
However, there is no clinical data demonstrating the mechanism of propofol can induce
transient DI by inhibiting the release of AVP from the hypothalamus when applied to humans.
Remifentanil, binding to the μ-receptor or partly κ-receptor, have been used in total
intravenous anesthesia combined with propofol, also reported inhibiting AVP relaese in both
the hypothalamus (κ receptor mediator mechanism) and posterior pituitary (μ receptor mediator
mechanism). However, the effects of anesthetics on water homeostasis during surgery have been
not well established. Therefore, we aim to investigate the changes of intraoperative water
homeostasis, and related hormones and osmolality in patients with propofol based total
intravenous anesthesia due to neuromonitoring for spine surgery.
Description:
"All patients will get the total intravenous anesthesia with propofol-remifentanil via an
effective site-controlled infusion (TCI). For this, TCI continuous infusion pump will be used
with Schnider pharmacokinetic model for propofol and Minto pharmacokinetic model for
remifentanil. Propofol and remifentanil will be initiated with target effective site
concentrations of 3 μg.ml-1 and 3 ng.ml-1, respectively, and controll these concentrations
considering patient's consciousness loss and vital signs. And then 0.6 mg kg-1 rocuronium for
muscle relaxation will be administered for intubation. Anesthesia will be maintained with BIS
level 40-60 and vital signs will not be more than 20% of the baseline or less. In order to
prevent the sudden movement of the patient during surgery, rocuronium will be infused
continuously about 50% of TOF until the end of intraoperative neuromonitoring.
