Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE August 10, 2010
First Posted Date  ICMJE August 11, 2010
Results First Submitted Date  ICMJE June 9, 2016
Results First Posted Date  ICMJE August 30, 2016
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
Post-operative Pain Using Verbal Rating Scale (VRS) [ Time Frame: 1 month ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
  • Opioid consumption obtained from the recorded data [ Time Frame: 1 month ]
    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 ]
    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 ]
    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 ]
    0= Not satisfied 100= Excellent
  • Hospital stay [ Time Frame: up to 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esmolol Infusion During Laminectomy: Effect on Quality of Recovery
Official Title  ICMJE Esmolol Infusion for Maintaining Hemodynamic Stability During Single or Double Level Lumbar Laminectomy: Effect on Quality of Recovery.
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Condition  ICMJE Laminectomy
Intervention  ICMJE
  • 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
  • Drug: Saline
    Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo: Will receive a normal saline bolus during induction, and an infusion of normal saline intraoperatively
    Intervention: Drug: Saline
  • Active Comparator: Esmolol
    Will receive Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
    Intervention: Drug: Esmolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 3, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)
64
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • American Society of Anesthesiologists (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 congestive heart failure (CHF) or bronchospasm, or patients with second- or third-degree heart block, symptomatic sinus bradyarrhythmia, or nonsinus rhythm on preoperative EKG.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01179113
Other Study ID Numbers  ICMJE Pro00019850
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
Principal Investigator: Roya Yumul, MD., PhD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP