Esmolol Infusion During Laminectomy: Effect on Quality of Recovery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01179113|
Recruitment Status : Terminated (The preliminary result didn't show any benefit.)
First Posted : August 11, 2010
Results First Posted : August 30, 2016
Last Update Posted : November 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Laminectomy||Drug: Esmolol Drug: Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Esmolol Infusion for Maintaining Hemodynamic Stability During Single or Double Level Lumbar Laminectomy: Effect on Quality of Recovery.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Placebo Comparator: Placebo
Placebo: Will receive a normal saline bolus during induction, and an infusion of normal saline intraoperatively
Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group
Other Name: Placebo
Active Comparator: Esmolol
Will receive Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
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.
Other Name: Brevibloc
- Post-operative Pain Using Verbal Rating Scale (VRS) [ Time Frame: 1 day ]
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
- Opioid Consumption in PACU Obtained From the Recorded Data [ Time Frame: 1 day ]Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).
- Postoperative Nausea and Vomiting [ Time Frame: 1 day ]Number of participants that experienced Postoperative nausea and vomiting using at PACU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179113
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Roya Yumul, MD, PhD||Cedars-Sinai Medical Center|
|Principal Investigator:||Roya Yumul, MD., PhD||Cedars-Sinai Medical Center|