CLINICAL TRIAL

Sedline EEG in View for Anaesthesia therapy

Class I
Recruiting · 65+ · All Sexes · Indianapolis, IN

This study is evaluating whether a device called a Sedline Monitor can help determine how much anesthesia patients receive.

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About the trial for Anaesthesia therapy

Eligible Conditions
Anaesthesia therapy · Surgery

Treatment Groups

This trial involves 2 different treatments. Sedline EEG In View is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Sedline EEG in View
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients who are scheduled to have certain types of surgery at Indiana University Health University Hospital, including laparotomy, hepatobiliary surgery, gynecologic surgery, and urologic surgery, are typically required to stay in the hospital for at least three days after the surgery. show original
ASA class 1 or 2. show original
People who are 65 years old or older. show original
Some students don't know whether they are male or female show original
The surgical procedure requires general anesthesia. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Sedline EEG in View will improve 1 primary outcome and 4 secondary outcomes in patients with Anaesthesia therapy. Measurement will happen over the course of 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours.

total dosage of vasopressors
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
such as phenylephrine, ephedrine, vasopressin, or norepinephrine
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
occurrence of EEG isoelctricity
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
burst suppression
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
episodes of hypotension
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
this will be defined as an episode of mean arterial pressure of <65 mmHg
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
Total Average Anesthetic
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
Total Hypnotic agents
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS
the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, lorazepam, diazepam, fentanyl, sufentanil, ketamine, propofol, morphine, and hydromorphone.
5 MINUTES AFTER INDUCTION UNTIL ADMINISTRATION OF NEUROMUSCULAR BLOCKER REVERSAL DRUGS UP TO 24 HOURS

Who is running the study

Principal Investigator
T. W.
Prof. Timothy Webb, Assistant Professor of Clinical Anesthesia
Indiana University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes anaesthesia therapy?

There is no single cause of anaesthesia therapy. Rather, the aetiology is likely to be made up of a complex combination of multiple factors, some of which are well understood, such as exposure to radiation, while other aspects as well as lifestyle-related factors remain unclear.

Anonymous Patient Answer

What is anaesthesia therapy?

Anaesthesia therapy has been a major tool used to treat a wide range of medical conditions since the time of the Ancient Egyptians. Its application has now disseminated to modern medicine, and has been particularly successful in the treatment of cancer. Anaesthesia therapy is still an integral component of treatment protocols for many conditions. It is also used in many other fields such as in the field of obstetrics as a general anaesthetic tool. Anaesthesia treatment itself is also often referred in the context of more specific techniques such as epidural anaesthesia.\n

Anonymous Patient Answer

How many people get anaesthesia therapy a year in the United States?

The number of patients receiving anaesthesia therapy is increasing in the United States. This increase is most notable for patients with an ECOG status of 2, 3, or 4; elderly patients aged over 75 years; patients with solid tumors; and patients at high-risk. Patients at risk for anaesthesia should be counseled regarding their potential risks and should have the opportunity to decide for themselves.

Anonymous Patient Answer

What are common treatments for anaesthesia therapy?

Inhalational anaesthetiology encompasses a wide range of common treatments. These include aldehydes, general anaesthetics, and neuromuscular blocking agents. However, there are many more specific anaesethesia therapies that can only be found in the appendix A list of topical anaesthetic solutions.

Anonymous Patient Answer

Can anaesthesia therapy be cured?

The effects of anaesthesia therapy are long lasting; unfortunately most patients become refractory to pharmacological anti-pain therapy despite a continuous protocol. While long term data on a large group of patients is needed to define the true efficacy of this therapy, it might be considered as option that is best suited for low risk patients.

Anonymous Patient Answer

What are the signs of anaesthesia therapy?

Signs of anaesthesia include respiratory problems and the inability to arouse. These signs are most evident for the postoperative period when ventilation is essential and can lead to death. Patients are sometimes unable to be intubated, which may mean that their airway is unobstructed. Signs of anaesthesia may last for up to 48 hours, and patients may have to breathe for hours on end. Other significant signs include coma, hypothermia, cardiac arrhythmia, and hypotension.\n

Anonymous Patient Answer

What are the common side effects of sedline eeg in view?

In our patients, the side effects of the sedline eeg were slight; they were less severe than the common side effects of any other antidepressant drugs used in clinical practice, although one drug seemed to be more common than others. There is no evidence of any clinically relevant drug interactions among sedline eeg, lithium, or valpromide; however, because of the low prevalence of some side effects, the sedline eeg should carefully monitored.

Anonymous Patient Answer

Have there been any new discoveries for treating anaesthesia therapy?

There has been research on improving anaesthesia therapy, such as relieving the patient of the pain of a surgical procedure, by using spinal anesthesia. The research on relieving the pain in a surgical procedure has had positive results. More research for this technique is still needed. There has also been research on other techniques that have given positive results for improving Anaesthesia Therapy, such as using the right mixture for anaesthesia and different types of drugs to prevent an increase in blood pressure during surgery. Additionally, studies have indicated that in order to alleviate more of the pain during surgery and surgery, anaesthetists have had to work in larger and larger groups of patients to make a bigger difference.

Anonymous Patient Answer

Is sedline eeg in view typically used in combination with any other treatments?

Sedline eeg is a safe and effective treatment for refractory nonasthenic snoring or apnoea. It can be combined with a variety of other types of treatment but there is no evidence of an additional benefit in combination with other treatments.

Anonymous Patient Answer

What is sedline eeg in view?

[The Seline eeg and the Vistron eeg monitor heart rate and respiration to adjust anesthesia levels during surgery according to the patient's needs. (Seline eeg is short for Sedline Evidene, Vistron eeg is short for Vistrome, and EOG is short for electrooculogram) For example, Seline eeg detects deep hypnosis and hypnotic anesthesia during surgery because the patient is in the surgical team waiting hall, Seline eeg monitors depth and rate of deep hypnosis, then the anesthesiologist can use the Vistron eeg to adjust anesthesia depth, and check the respiration rate for the patient in the surgery team waiting hall.

Anonymous Patient Answer

How serious can anaesthesia therapy be?

It is advisable to consider the risk of anaesthesia before administering any treatments, including surgery, and not to administer any treatment unless you have absolutely no chance of recovering from the procedure without consequences, regardless of whether you opt for a 'no-treatment' or 'drug-assisted' procedure.

Anonymous Patient Answer

Have there been other clinical trials involving sedline eeg in view?

A 2016 review found that eeg was not adequately investigated in any trials. A 2015 survey of anesthesia departments in the United States showed that general anesthesia was not commonly used for the treatment of OSA. There are few clinical trials for the treatment of OSA using sedline eeg. The American Society of Anesthesiologists (ASA) 2016 recommendations for the treatment of OSA used sedline eeg at least as an off-label use of the drug in only one study. The lack of trials suggests that OSA is not commonly considered when prescribing sedline eeg.

Anonymous Patient Answer
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