Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 280
Inclusion Criteria
- Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
- Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Exclusion Criteria
- Pregnant or breastfeeding
- 2nd or 3rd degree heart block as assessed by preoperative EKG
- Use of long acting opioids pre-operatively 28 days prior to day of surgery
- ...
- Pregnant or breastfeeding
- 2nd or 3rd degree heart block as assessed by preoperative EKG
- Use of long acting opioids pre-operatively 28 days prior to day of surgery
- Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
- Planned use of an epidural for surgery or post-operative pain relief
- Use of dexmedetomidine within 28 days prior to day of surgery
- Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
- Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
- Contraindication to use of NSAID, Acetaminophen or IV opioids.
- Any known hypersensitivity to dexmedetomidine
Summary
- Conditions
- Pain
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.
The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.
Inclusion Criteria
- Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
- Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Exclusion Criteria
- Pregnant or breastfeeding
- 2nd or 3rd degree heart block as assessed by preoperative EKG
- Use of long acting opioids pre-operatively 28 days prior to day of surgery
- ...
- Pregnant or breastfeeding
- 2nd or 3rd degree heart block as assessed by preoperative EKG
- Use of long acting opioids pre-operatively 28 days prior to day of surgery
- Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
- Planned use of an epidural for surgery or post-operative pain relief
- Use of dexmedetomidine within 28 days prior to day of surgery
- Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
- Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
- Contraindication to use of NSAID, Acetaminophen or IV opioids.
- Any known hypersensitivity to dexmedetomidine
Tracking Information
- NCT #
- NCT01973452
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alessia Pedoto, MD Memorial Sloan Kettering Cancer Center
- Alessia Pedoto, MD Memorial Sloan Kettering Cancer Center
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