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Esmolol Infusion During Laminectomy: Effect on Quality of Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01179113
First received: August 10, 2010
Last updated: August 5, 2013
Last verified: August 2013
  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:


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 November 27, 2014