Esmolol Infusion During Laminectomy: Effect on Quality of Recovery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Laminectomy	Drug: Esmolol	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver)
Official Title:	Esmolol Infusion for Maintaining Hemodynamic Stability During Laminectomy: Effect on Quality of Recovery

Resource links provided by NLM:

Drug Information available for: Esmolol hydrochloride

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

Post-operative pain using Verbal Rating Scale (VRS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
It will be evaluated the effects of intraoperative esmolol infusion, which is commonly used to help maintain hemodynamic stability intraoperatively, on postoperative pain scores after single or two-level lumbar laminectomies.

The information will be recorded by study staff and data obtained from patient and patient charts.

After discharge data will be obtained from the follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery

Secondary Outcome Measures:

Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery)
Postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
Return to normal activities of daily living using follow up questionnaires [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Description: return to normal activities of daily living (including dietary intake, bowel and bladder function, physical activities)
Patient satisfaction using a verbal rating scale from 0 to 100 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
0= Not satisfied 100= Excellent
Hospital stay [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]


Estimated Enrollment:	64
Study Start Date:	June 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo This group: Will receive a normal saline bolus during induction, and an infusion of normal saline 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. Other Name: Brevibloc
Active Comparator: Esmolol	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. Other Name: Brevibloc

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled to undergo single-level or double-level laminectomy under general anesthesia
Willingness and ability to sign an informed consent document
No allergies to any of the anesthetic or analgesic medications being used for the study, as outlined in the study protocol
Between 18-80 years of age
ASA class I-III adults of either sex

Exclusion Criteria:

Patients who are ASA class IV or higher
Patients with known allergy, hypersensitivity, or contraindication to the use of any of the medications being used for the study, as outlined in the study protocol
Patients who are heavy chronic opioid users, defined for the purposes of this study as any patient who is taking the equivalent of 10mg of oral morphine per day or greater
Pregnant or lactating women
Patients with a history of drug or alcohol abuse within the past 3 months
Patients with any other medical conditions or who are using any medications which may interfere with the conduct of the study (including patients taking clonidine, patients with EKG conduction defects and who are taking calcium channel blockers, patients with clinically significant CHF or bronchospasm, or patients with second- or third-degree heart block, symptomatic sinus bradyarrhythmia, or nonsinus rhythm on preoperative EKG.)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179113

Contacts


Contact: Paul F White, MD, PhD	(214)648-6424	paul.white@utsouthwestern.edu
Contact: Ofelia L Elvir-Lazo, MD	(310) 423-4414	loanidoc@yahoo.com

Locations


United States, California
Cedars Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Sub-Investigator: Christine Lennon, Md, PhD
Sub-Investigator: Ronald H Wender, MD

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators


Principal Investigator:	Roya Yumul, MD, PhD	Cedars-Sinai Medical Center
Principal Investigator:	Roya Yumul, MD., PhD	Cedars-Sinai Medical Center

More Information

No publications provided


Responsible Party:	Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT01179113 History of Changes
Other Study ID Numbers:	Pro00019850
Study First Received:	August 10, 2010
Last Updated:	August 5, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:


Laminectomy Esmolol Infusion Quality of recovery beta-blockers Pain management	Postoperative pain Opioid requirements Intraoperative esmolol infusion Return to normal activities of daily living

Additional relevant MeSH terms:


Esmolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists	Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015