A Phase 4 interventional study of Esmolol and Saline in Laminectomy, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Cedars-Sinai Medical Center · Phase 4 and Interventional
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.
Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo: Will receive a normal saline bolus during induction, and an infusion of normal saline intraoperatively
Drug: Saline
Will receive Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Drug: Esmolol
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.
Also known as: Brevibloc
Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group
Also known as: Placebo
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
Time frame: 1 day
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).
Time frame: 1 day
Postoperative Nausea and Vomiting
Number of participants that experienced Postoperative nausea and vomiting using at PACU
Time frame: 1 day
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.
| Milestone | Placebo | Esmolol |
|---|---|---|
| Started | 17 | 16 |
| Completed | 17 | 16 |
| Not completed | 0 | 0 |
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
| Scores on a scale | Placebo | Esmolol |
|---|---|---|
| Post-operative Pain Using Verbal Rating Scale (VRS) | 4 ± 4 | 5 ± 3 |
Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).
| mg | Placebo | Esmolol |
|---|---|---|
| Opioid Consumption in PACU Obtained From the Recorded Data | 1.5 ± 0.6 | 2 ± 2.6 |
Number of participants that experienced Postoperative nausea and vomiting using at PACU
| participants | Placebo | Esmolol |
|---|---|---|
| Postoperative Nausea and Vomiting | 2 | 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/17 (0%) | 0/17 (0%) |
| Esmolol | — | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Placebo | Esmolol | Total |
|---|---|---|---|
| Mean | 59 ± 11 | 54 ± 16 | 57 ± 14 |
| Sex: Female, Male(Participants) | Placebo | Esmolol | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 9 | 9 | 18 |
| Region of Enrollment(participants) | Placebo | Esmolol | Total |
|---|---|---|---|
| United States | 17 | 16 | 33 |
| Body Mass Index (BMI)(kg/m^2) | Placebo | Esmolol | Total |
|---|---|---|---|
| Mean | 26 ± 5 | 26 ± 4 | 26 ± 5 |
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cedars-Sinai Medical Center