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

NCT ID: NCT00345384

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-01-31

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.

Conditions

Post-operative Pain; Respiratory Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Normal Saline

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

Group Type: PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine titrated over 24 hours

Interventions

Dexmedetomidine

Dexmedetomidine titrated over 24 hours

Intervention Type: DRUG

Placebo (Normal Saline)

Intervention Type: OTHER

Other Intervention Names

Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Ramsay, MD, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center - Department of Anesthesiology

Dallas, Texas, United States

Countries

United States

Other Identifiers

005-201

Identifier Type: -

Identifier Source: org_study_id