Esmolol Infusion During Laminectomy: Effect on Quality of Recovery

NCT01179113 | Terminated Phase 4 Results

• 1 other identifier: Pro00019850
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Laminectomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (2)

• Opioid Consumption in PACU Obtained From the Recorded Data

  1 day

• Postoperative Nausea and Vomiting

  1 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo: Will receive a normal saline bolus during induction, and an infusion of normal saline intraoperatively

Drug: Saline

Esmolol

ACTIVE COMPARATOR

Will receive Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively

Drug: Esmolol

Interventions

Esmolol DRUG

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

Esmolol

Saline DRUG

Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

esmolol; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Roya Yumu', Anesthesiology Program Director
• Organization: Cedars Sinai Medical Center

Roya.Yumul@cshs.org

310-423-1682

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Roya Yumul, MD., PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: June 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 2, 2016
• Results First Posted: August 30, 2016

Record last verified: 2016-09

Locations

US (1)