Water Homeostasis in Propofol Based Total Intravenous Anesthesia

The Effect of Propofol Based Total Intravenous Anesthesia for Neuromonitoring on the Intraoperative Water Homeostasis in in Spine Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Spine Surgery With Neuromonitoring
• Intervention / Treatment: Procedure: A patient who need the cerebral artery aneurysm clipping 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 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Myoung Hwa Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo spine surgery with neuromonitoring

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A patient who need the spine surgery; A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for spine surgery	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The water homeostasis changes of patients during propofol based total intravenous anesthesia for neuromonitoring in spine surgery	The amount of urine (polyuria standard> 5 ml/kg/h) during surgery	The change over time during surgery: baseline (before operation, T1), one hour after operation (T2), two hours after operation (T3), and three hours after operation (T4) - measure at four times

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative polyuria (or diabetes insipidus)	Incidence of postoperative polyuria (or diabetes insipidus)	At postoperative 24 hours and 48 hours

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 3-2019-0142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No