Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345384
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2006-06-27
Brief Title:
Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None