Water Homeostasis in Propofol Based Total Intravenous Anesthesia

NCT04058106 | Withdrawn

• 1 other identifier: 3-2019-0142
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Surgery With Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative polyuria (or diabetes insipidus)

  At postoperative 24 hours and 48 hours

Study Arms (1)

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

Interventions

A patient who need the cerebral artery aneurysm clipping surgery PROCEDURE

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

A patient who need the spine surgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo spine surgery with neuromonitoring

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Myoung Hwa Kim

Seoul, 06273, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 15, 2019
• Study Start: August 19, 2019
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

KR (1)