Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
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.
Post-Operative Respiratory Depression
Drug: Dexmedetomidine administration for 24 hours after discharge from the PACU or ICU.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- Evaluate the safety of low-dose dexmedetomidine in providing analgesia postoperatively for up to 24 hours on a general nursing unit post discharge from either the Intensive Care or Post Anesthesia Recovery Unit
- Evaluate postoperatively hemodynamic stability by monitoring and recording vital signs
- Evaluate post-operative respiratory patterns measured by respiratory rate, oxygen saturation (SPO2) and transcutaneous carbon dioxide levels (TCPCO2) and level of sedation (using the Ramsay Sedation Scale)
- Evaluate the efficacy of low-dose dexmedetomidine in providing a decrease in opioid medication and self-administration in post-operative surgical in-patients undergoing thoracic surgery
|Study Completion Date:||January 2008|
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 dexmedomidine 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345384
|United States, Texas|
|Baylor University Medical Center - Department of Anesthesiology|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Michael Ramsay, MD, MD||Baylor Health Care System|