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The preliminary result didn't show any benefit.
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The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly administered during surgery to help control blood pressure and heart rate, on postoperative pain levels and requirements for pain medication.
A common practice used to control autonomic responses during surgery is to administer beta-blockers intraoperatively. This practice has been shown to effectively blunt autonomic responses to intraoperative events. Several studies have shown that administration of beta-blockers can decrease intraoperative anesthetic requirements. Additionally, it has been demonstrated in several studies that intraoperative beta-blocker administration may actually decrease postoperative pain scores and opioid requirements, although these results are not entirely consistent. The mechanism by which the decrease in postoperative pain and narcotic requirements occurs is unclear. It has been postulated that esmolol may itself possess some analgesic-like properties, as was suggested by studies performed in rodent models. It has also been postulated that perioperative beta-blockade may attenuate the neuroendocrine stress response to surgery, thereby decreasing inflammatory responses in tissues; however, this theory was not supported by a study in which stress hormone levels were measured in patients who received beta-blockers and compared to a control group. Several studies which investigated the effects of beta-blockade on postoperative pain and opioid requirements compared the beta-blocker treatment group to an opioid treatment group, and did not include a true control group in which no treatment was given. Therefore, it is unclear whether the decrease in postoperative pain and opioid requirements in these studies was due to a true effect of the beta-blockers or whether it was due to an effect of the opioids.
Therefore, the investigators propose a randomized, double-blinded, placebo-controlled study in which the investigators will compare an esmolol infusion treatment group to a normal saline infusion control group with regards to the effects on postoperative pain and opioid requirements. By setting up the study in this manner, the investigators will be able to clearly evaluate the effects of beta-blockers on postoperative pain scores and opioid requirements. The investigators chose to use esmolol both because it has a short half-life, so it is easy to titrate and administer as an infusion, and also because it is selective for beta-1 receptors, so deleterious effects of intraoperative hypotension should be minimized. The investigators chose to perform the study on patients who are undergoing single-level or double-level laminectomies because prior studies have investigated the effects of intraoperative beta-blockers on patients who are not chronic pain patients, and the investigators would like to research whether the results which have been suggested by prior studies are also applicable to patients who may have chronic pain, as this is the patients population that is most likely to experience high pain levels following surgery, and may benefit the most from reduction of postoperative pain levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo: Will receive a normal saline bolus during induction, and an infusion of normal saline intraoperatively |
|
| Esmolol | Active Comparator | Will receive Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmolol | Drug | Esmolol group: Will receive 0.5 mg/kg IV bolus of esmolol during induction, and an infusion of esmolol at 0.3 mg/kg/hr intraoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Using Verbal Rating Scale (VRS) | Verbal Rating Scale goes from 0 to 10, where: 0 indicates= No pain" and 10 indicates= The worst possible pain The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption in PACU Obtained From the Recorded Data | Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts). | 1 day |
| Postoperative Nausea and Vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Roya Yumul, MD., PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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Prior to the day of surgery, potential study patients scheduled to undergo spine surgical procedures received a packet of materials from their surgeon. The packet contained an initial patient contact letter, a privacy information sheet, and the institution review board (IRB)-approved informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A normal saline bolus during induction, and an infusion of normal saline intraoperatively. |
| FG001 | Esmolol | Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A normal saline bolus during induction, and an infusion of normal saline intraoperatively. |
| BG001 | Esmolol | Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Pain Using Verbal Rating Scale (VRS) | Verbal Rating Scale goes from 0 to 10, where: 0 indicates= No pain" and 10 indicates= The worst possible pain The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay | Posted | Mean | Standard Deviation | Scores on a scale | 1 day |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | A normal saline bolus during induction, and an infusion of normal saline intraoperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roya Yumu', Anesthesiology Program Director | Cedars Sinai Medical Center | 310-423-1682 | Roya.Yumul@cshs.org |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group |
|
|
Number of participants that experienced Postoperative nausea and vomiting using at PACU
| 1 day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Opioid Consumption in PACU Obtained From the Recorded Data | Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts). | Posted | Mean | Standard Deviation | mg | 1 day |
|
|
|
| Secondary | Postoperative Nausea and Vomiting | Number of participants that experienced Postoperative nausea and vomiting using at PACU | Posted | Number | participants | 1 day |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Esmolol | Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively | 0 | 16 | 0 | 16 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D017670 |
| Sodium Compounds |