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Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00345384
First received: June 27, 2006
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.

Condition Intervention Phase
Post-operative Pain
Respiratory Depression
Drug: Dexmedetomidine
Other: Placebo (Normal Saline)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Post-Operative Infusion of Low-Dose Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients: A Randomized, Double-Blind, Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. [ Time Frame: An average of 24 hours, up to 30 hours per patient ] [ Designated as safety issue: No ]
    To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.


Secondary Outcome Measures:
  • Measure the Amount of Respiratory Depression in Each Groups [ Time Frame: Hours 6 to 16 ] [ Designated as safety issue: Yes ]
    Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.


Enrollment: 38
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug.
Other: Placebo (Normal Saline)
Active Comparator: Dexmedetomidine
The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU
Drug: Dexmedetomidine
Dexmedetomidine titrated over 24 hours
Other Name: Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1

Detailed Description:

Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedetomidine is not approved for use longer than twenty-four hours and must only be administered in the Intensive Care Unit where patients can be continuously monitored.

This is a prospective, double-blinded, control group pilot study. One group (the control group) will receive a normal saline infusion and the second group (the treatment group) will receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open nursing unit (not an Intensive Care Unit).

During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical procedure after an optional loading dose. All patients will receive pain medication using a Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the incision under direction of the surgeon.

Before discharge from the PACU or ICU, each subject will receive either low-dose dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after the subject is discharged from either the PACU or the ICU to an open nursing unit. While on the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score will recorded every two hours until the treatment drug is stopped.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I, II or III
  • Undergoing thoracic surgery on an inpatient basis
  • Age 18 up to 85 years of age

Exclusion Criteria:

  • Subject is pregnant and/or lactating
  • Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival.
  • Subject for whom alpha-2 agonists are contraindicated
  • Subject meets any of the following cardiovascular criteria:
  • Acute unstable angina (defined during current hospital stay)
  • Suspicion of acute myocardial infarction.
  • Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not exclusion criteria.
  • Subject has participated in a trial with any experimental drug within 30 days prior to enrollment in the study, or has ever been enrolled in this study.
  • Subject is unable to undergo any procedures required by the protocol.
  • Subject has acute hepatitis, a history or presence of chronic hepatitis, and /or has had a positive result for Hepatitis B surface antigen test.
  • Subject requires dialysis (e.g., hemodialysis, peritoneal dialysis, CVVHD).
  • Subject has a known, uncontrolled seizure disorder.
  • Subject has a known psychiatric illness that could confound a normal response to sedative treatment.
  • Subject is terminally ill with a life duration expectancy of < 60 days.
  • Subject has a history of Obstructive Sleep Apnea.
  • Oxygen saturation is < 90% on room air.
  • Subject is on beta blocker medication.
  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: NCT00345384

Locations
United States, Texas
Baylor University Medical Center - Department of Anesthesiology
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Michael Ramsay, MD, MD Baylor Health Care System
  More Information

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00345384     History of Changes
Other Study ID Numbers: 005-201 
Study First Received: June 27, 2006
Results First Received: August 10, 2011
Last Updated: January 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
Dexmedetomidine
Sedation
Opioid
Respiratory depression

Additional relevant MeSH terms:
Depression
Pain, Postoperative
Respiratory Insufficiency
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
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

ClinicalTrials.gov processed this record on December 02, 2016