Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04058106
Status:
WITHDRAWN
Last Update Posted:
2021-07-20
First Post:
2019-07-23
Brief Title:
Water Homeostasis in Propofol Based Total Intravenous Anesthesia
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
The Effect of Propofol Based Total Intravenous Anesthesia for Neuromonitoring on the Intraoperative Water Homeostasis in in Spine Surgery
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NO Participants Enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 μgml-1 and 3 ngml-1 respectively and controll these concentrations considering patients consciousness loss and vital signs And then 06 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None