Anesthesia, Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESedline EEG in View
EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing a scheduled surgery (laparotomy, hepatobiliary surgery, gynecologic surgery, and/or urologic surgery procedures) at Indiana University Health University Hospital that is expected to have at least a 3 day post-operative hospital stay. * ASA class 1, 2, 3, or 4. * Age 65 years or older. * Male or Female * Surgical procedure requiring general anesthesia.
Exclusion criteria
* Any previous diagnosis of dementia or other cognitive impairment. * Any patient undergoing emergency surgery. * Any patient undergoing surgery who is currently an inpatient. * Patient refusal to participate in study. * Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp). * Any physical, mental, or medical conditions which, in the opinion of the investigators, may confound the ability to assess the patient for delirium in the post-operative period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Average Anesthetic | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Period of Hypotension | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | this will be defined as an episode of mean arterial pressure of \<65 mmHg |
| Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | phenylephrine, norepinephrine |
| Occurrence of EEG Isoelctricity | 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours | 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) |
| Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone. |
| Total Dosage of Vasopressor (Vasopressin) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | vasopressin |
| Total Hypnotic Agents (Fentanyl) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl. |
| Total Dosage of Vasopressor (Ephedrine) | 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given | ephedrine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery. | 51 |
| Control Group Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | Control Group | Study Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 51 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| ASA physical status ASA 2 | 7 Participants | 1 Participants | 8 Participants |
| ASA physical status ASA 3 | 43 Participants | 49 Participants | 92 Participants |
| ASA physical status ASA 4 | 1 Participants | 1 Participants | 2 Participants |
| Baseline Diastolic Blood Pressure | 80 mmHg STANDARD_DEVIATION 15 | 74 mmHg STANDARD_DEVIATION 12 | 77 mmHg STANDARD_DEVIATION 14 |
| Baseline Systolic Blood Pressure | 139 mmHg STANDARD_DEVIATION 22 | 131 mmHg STANDARD_DEVIATION 19 | 135 mmHg STANDARD_DEVIATION 21 |
| BMI | 27 kilograms / meters^2 STANDARD_DEVIATION 6 | 27 kilograms / meters^2 STANDARD_DEVIATION 6 | 27 kilograms / meters^2 STANDARD_DEVIATION 6 |
| Height | 171 centimeters STANDARD_DEVIATION 11 | 171 centimeters STANDARD_DEVIATION 12 | 171 centimeters STANDARD_DEVIATION 11 |
| Opioid Naïve or Tolerant Naïve | 35 Participants | 44 Participants | 79 Participants |
| Opioid Naïve or Tolerant Tolerant | 16 Participants | 7 Participants | 23 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 51 participants | 51 participants | 102 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 31 Participants | 30 Participants | 61 Participants |
| Type of Surgery GI/Colorectal | 31 Participants | 33 Participants | 64 Participants |
| Type of Surgery GYN | 0 Participants | 2 Participants | 2 Participants |
| Type of Surgery Other | 2 Participants | 0 Participants | 2 Participants |
| Type of Surgery Urologic | 18 Participants | 16 Participants | 34 Participants |
| Weight | 79 kilograms STANDARD_DEVIATION 20 | 80 kilograms STANDARD_DEVIATION 20 | 80 kilograms STANDARD_DEVIATION 20 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Total Average Anesthetic | 1.1890 percentage of sevoflurane | Standard Deviation 0.2571 |
| Control Group | Total Average Anesthetic | 1.2906 percentage of sevoflurane | Standard Deviation 0.2069 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Occurrence of EEG Isoelctricity | 13.60 % (of case with burst suppression) | Standard Deviation 24.85 |
| Control Group | Occurrence of EEG Isoelctricity | 21.28 % (of case with burst suppression) | Standard Deviation 32.58 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Time Period of Hypotension | 27.18 minutes (with MAP < 65) | Standard Deviation 31.43 |
| Control Group | Time Period of Hypotension | 27.41 minutes (with MAP < 65) | Standard Deviation 34.52 |
Secondary
Total Dosage of Vasopressor (Ephedrine)
ephedrine
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Total Dosage of Vasopressor (Ephedrine) | 17.06 mg | Standard Deviation 18.26 |
| Control Group | Total Dosage of Vasopressor (Ephedrine) | 13.86 mg | Standard Deviation 22.9 |
Secondary
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
Population: Please note, the units listed below are the standard units used in clinical practice for these medications
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | Phenylephrine | 1442.55 mcg | Standard Deviation 1489.29 |
| Study Group | Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | Norepinephrine | 79.45 mcg | Standard Deviation 70.08 |
| Control Group | Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | Phenylephrine | 4077.20 mcg | Standard Deviation 2845.07 |
| Control Group | Total Dosage of Vasopressor (Norepinephrine, Phenylephrine) | Norepinephrine | 374.62 mcg | Standard Deviation 330.02 |
Secondary
Total Dosage of Vasopressor (Vasopressin)
vasopressin
Time frame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Total Dosage of Vasopressor (Vasopressin) | 0.84 Units | Standard Deviation 0.59 |
| Control Group | Total Dosage of Vasopressor (Vasopressin) | 2.63 Units | Standard Deviation 1.84 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Total Hypnotic Agents (Fentanyl) | 139.22 mcg | Standard Deviation 69.33 |
| Control Group | Total Hypnotic Agents (Fentanyl) | 173.04 mcg | Standard Deviation 101.22 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Midazolam | 1.29 mg | Standard Deviation 1.46 |
| Study Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Ketamine | 43.98 mg | Standard Deviation 38.54 |
| Study Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Hydromorphone | 0.39 mg | Standard Deviation 0.57 |
| Study Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Methadone | 1.18 mg | Standard Deviation 0.8 |
| Control Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Methadone | 4.07 mg | Standard Deviation 3.31 |
| Control Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Midazolam | 1.49 mg | Standard Deviation 1.46 |
| Control Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Hydromorphone | 0.41 mg | Standard Deviation 0.47 |
| Control Group | Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone) | Ketamine | 45.40 mg | Standard Deviation 42.95 |