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

Primary Purpose

Post-operative Pain, Respiratory Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo (Normal Saline)
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Dexmedetomidine, Sedation, Opioid, Respiratory depression

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor University Medical Center - Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal Saline

Dexmedetomidine

Arm Description

One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug.

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

Outcomes

Primary Outcome Measures

Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.
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
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.

Full Information

First Posted
June 27, 2006
Last Updated
January 12, 2016
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00345384
Brief Title
Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Respiratory Depression
Keywords
Dexmedetomidine, Sedation, Opioid, Respiratory depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug.
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1
Intervention Description
Dexmedetomidine titrated over 24 hours
Intervention Type
Other
Intervention Name(s)
Placebo (Normal Saline)
Primary Outcome Measure Information:
Title
Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.
Description
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.
Time Frame
An average of 24 hours, up to 30 hours per patient
Secondary Outcome Measure Information:
Title
Measure the Amount of Respiratory Depression in Each Groups
Description
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.
Time Frame
Hours 6 to 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Ramsay, MD, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University Medical Center - Department of Anesthesiology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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