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Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

This study is currently recruiting participants.
Verified December 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03325972
First Posted: October 30, 2017
Last Update Posted: December 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.

Condition Intervention Phase
Chronic Pain Drug: Dexmedetomidine Other: Placebo Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Morphine equivalents used during the first 48 hours after surgery [ Time Frame: 48 Hours ]
    Amount of morphine administered during the 48 hours following surgery


Secondary Outcome Measures:
  • Numeric Pain Rating Scale (NRS) scores during the first 48 hours [ Time Frame: 48 Hours ]
    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

  • Numeric Pain Rating Scale (NRS) scores at 6 weeks post surgery [ Time Frame: 6 Weeks ]
    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.


Estimated Enrollment: 130
Actual Study Start Date: September 14, 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV dexmedetomidine
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Drug: Dexmedetomidine
The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Placebo Comparator: Placebo
saline placebo
Other: Placebo Saline
Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
  • Subject is non-lactating and is either:
  • Not of childbearing potential
  • Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
  • Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

  • Subject is pregnant or breastfeeding
  • Any subject whom the investigators deem unable to complete any/all research related tasks
  • Subjects who are cognitively impaired (by history)
  • Subject requires antipsychotic medications
  • Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
  • Subject has known allergy to dexmedetomidine
  • Subjects with impaired renal or hepatic function
  • Subjects with advanced heart block
  • Subjects with severe ventricular dysfunction
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03325972


Contacts
Contact: Lola Franco 212 263 0531 lola.franco@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Lola Franco    212-263-0531    Lola.Franco@nyumc.org   
Principal Investigator: Lisa Doan, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Lisa Doan, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03325972     History of Changes
Other Study ID Numbers: 14-00915
First Submitted: October 26, 2017
First Posted: October 30, 2017
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action