Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
280

Inclusion Criterias

Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

Exclusion Criterias

Use of long acting opioids pre-operatively 28 days prior to day of surgery
Use of dexmedetomidine within 28 days prior to day of surgery
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
Use of dexmedetomidine within 28 days prior to day of surgery
2nd or 3rd degree heart block as assessed by preoperative EKG
Any known hypersensitivity to dexmedetomidine
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.
Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
Contraindication to use of NSAID, Acetaminophen or IV opioids.
Pregnant or breastfeeding
Planned use of an epidural for surgery or post-operative pain relief

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 Criterias

Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery

Exclusion Criterias

Use of long acting opioids pre-operatively 28 days prior to day of surgery
Use of dexmedetomidine within 28 days prior to day of surgery
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
Use of dexmedetomidine within 28 days prior to day of surgery
2nd or 3rd degree heart block as assessed by preoperative EKG
Any known hypersensitivity to dexmedetomidine
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.
Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
Contraindication to use of NSAID, Acetaminophen or IV opioids.
Pregnant or breastfeeding
Planned use of an epidural for surgery or post-operative pain relief

Locations

Harrison, New York, 10604
Basking Ridge, New Jersey
Commack, New York, 11725
New York, New York, 10065
...
Harrison, New York, 10604
Basking Ridge, New Jersey
Commack, New York, 11725
New York, New York, 10065

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