The purpose of our study is to determine if monitoring sedation (how asleep patients are under general anesthesia) using a device called a Sedline Monitor affects the amount of anesthesia patients receive.
The main objective of this study is to determine if monitoring sedation using the FDA approved device, Sedline Monitor, affects the amount of anesthesia patients 65 or older receive during surgery. Reducing the anesthetic dose could result in less exposure of anesthetic medications to a high-risk patient population as well as a potential reduction in cost. Subjects will be randomized into either a control group or study group and have the Sedline Monitor placed on their head before the start of their already scheduled surgery. During the surgery, subjects in the control group will receive standard anesthesia care and the study group will receive anesthetic drug doses guided by Sedline Monitor processed EEG characteristics. When the surgery is complete, the Sedline Monitor will be removed and subject participation will be finished. The study team will also collect information about subjects from their medical records and use it for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
110
EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
IU Health University Hospital
Indianapolis, Indiana, United States
Total Average Anesthetic
total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone.
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Time Period of Hypotension
this will be defined as an episode of mean arterial pressure of \<65 mmHg
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)
phenylephrine, norepinephrine
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Occurrence of EEG Isoelctricity
Following the procedure, images and data from the Sedline device were evaluated to determine what percentage of the case a patient's processed EEG displayed isoelectricity (burst suppression). A burst-suppression (or suppression-burst) pattern is a discontinuous EEG, with periods of marked suppression or isoelectric intervals alternating with "bursts" of activity, with or without embedded epileptiform features (Bauer et al., 2013)
Time frame: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours
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Total Dosage of Vasopressor (Ephedrine)
ephedrine
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Dosage of Vasopressor (Vasopressin)
vasopressin
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Hypnotic Agents (Fentanyl)
the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl.
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given