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

January 12, 2016 updated by: Baylor Research Institute

Post-Operative Infusion of Low-Dose Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients: A Randomized, Double-Blind, Controlled Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center - Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
An average of 24 hours, up to 30 hours per patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the Amount of Respiratory Depression in Each Groups
Time Frame: Hours 6 to 16
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.
Hours 6 to 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Michael Ramsay, MD, MD, Baylor Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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