Spine Surgery With NeuromonitoringNCT04058106
Water Homeostasis in Propofol Based Total Intravenous Anesthesia
An observational study of Spine Surgery With Neuromonitoring, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spine Surgery With Neuromonitoring
- What is being tested?
- A patient who need the cerebral artery aneurysm clipping surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2019to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients who undergo spine surgery with neuromonitoring
Who may be able to join
- Patients, ASA Classification I-Ⅲ between 20 and 70 years, scheduled the neuromonitoring for spine surgery in department of neurosurgery
Who cannot join
- 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
Show all 9Show fewer
- Taking lithium or antibiotics that are known to cause DI
- Do not understand Korean language
- Vulnerable subjects who are unable to obtain consent forms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spine Surgery With Neuromonitoring
- Being tested
- A patient who need the cerebral artery aneurysm clipping surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A patient who need the cerebral artery aneurysm clipping surgeryProcedure or surgery
A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for unruptured cerebral artery aneurysm clipping surgery
| Study group | Role | What they receive |
|---|---|---|
| A patient who need the spine surgery | A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for spine surgery Receives: Procedure: A patient who need the cerebral artery aneurysm clipping surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Incidence of postoperative polyuria (or diabetes insipidus)
Measured: At postoperative 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start19 Aug 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Why it stopped: NO Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine Surgery With NeuromonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myoung Hwa Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058106
- Sponsor's protocol ID
- 3-2019-0142
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propofol Based Total Intravenous Anesthesia for Neuromonitoring on the Intraoperative Water Homeostasis in in Spine Surgery
- ClinicalTrials.gov ID
- NCT04058106
- Acronym / sponsor ID
- 3-2019-0142
- Conditions
- Spine Surgery With Neuromonitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: NO Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A patient who need the spine surgery | – | Procedure: A patient who need the cerebral artery aneurysm clipping surgeryA patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for spine surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo spine surgery with neuromonitoring
Key inclusion criteria (1 listed)
- Patients, ASA Classification I-Ⅲ between 20 and 70 years, scheduled the neuromonitoring for spine surgery in department of neurosurgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A patient who need the cerebral artery aneurysm clipping surgeryA patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for unruptured cerebral artery aneurysm clipping surgery | Procedure or surgery | A patient who need the spine surgery |
Primary outcome
The water homeostasis changes of patients during propofol based total intravenous anesthesia for neuromonitoring in spine surgery
Time frame: 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
The amount of urine (polyuria standard> 5 ml/kg/h) during surgery
1 secondary outcome
Postoperative polyuria (or diabetes insipidus)
Time frame: At postoperative 24 hours and 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Surgery With Neuromonitoring, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The water homeostasis changes of patients during propofol based total intravenous anesthesia for neuromonitoring in spine surgery (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.