Water Homeostasis in Propofol Based Total Intravenous Anesthesia

NCT ID: NCT04058106

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-19

Study Completion Date

2021-07-15

Brief Summary

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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

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"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.

Conditions

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Spine Surgery With Neuromonitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A patient who need the spine surgery

A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for spine surgery

A patient who need the cerebral artery aneurysm clipping surgery

Intervention Type PROCEDURE

A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for unruptured cerebral artery aneurysm clipping surgery

Interventions

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A patient who need the cerebral artery aneurysm clipping surgery

A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for unruptured cerebral artery aneurysm clipping surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients, ASA Classification I-Ⅲ between 20 and 70 years, scheduled the neuromonitoring for spine surgery in department of neurosurgery

Exclusion Criteria

Taking thiazide/ACEi /ARB for hypertension

* Receiving insulin treatment due to diabetes mellitus
* Diagnosed with kidney disease or GFR \< 60
* Diagnosed with liver disease or AST/ALT \> 100
* Receiving furosemide or mannitol before surgery
* DI was diagnosed before surgery or having polyuria
* Taking lithium or antibiotics that are known to cause DI
* Do not understand Korean language
* Vulnerable subjects who are unable to obtain consent forms
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Myoung Hwa Kim

Department of Anesthesiology and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Myoung Hwa Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2019-0142

Identifier Type: -

Identifier Source: org_study_id

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