Pain
Conditions
Keywords
Dexmedetomidine, Opioid, Thoracic Surgery
Brief summary
The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food & Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.
Detailed 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.
Interventions
DRUGDexmedetomidine
DRUGPlacebo
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
Exclusion criteria
* 2nd or 3rd degree heart block as assessed by preoperative EKG * Use of dexmedetomidine within 28 days prior to day of surgery * Use of long acting opioids pre-operatively 28 days prior to day of surgery * 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. * Documentation of congestive heart failure and Ejection fraction \< 30% if recorded in the Pre-Operative Record. * Planned use of an epidural for surgery or post-operative pain relief * Contraindication to use of NSAID, Acetaminophen or IV opioids. * Any known hypersensitivity to dexmedetomidine * Pregnant or breastfeeding * Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (\> 75 U/L)? * Abnormal renal function tests as related to contraindications to use of IV Ketorolac Yes or No?; Is Serum Creatinine \< 1.5 mg/dl?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Administered | up to 4 hours | total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improves Analgesia | up to 24 hours | as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible' |
| Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | up to 24 hours | as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine continuous infusion of 0.4 mcg/kg/hr
Dexmedetomidine | 148 |
| Placebo continuous infusion of 0.4 mcg/kg/hr
Placebo | 152 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Surgery canceled by participant | 5 | 3 |
| Overall Study | Withdrawal by Subject | 10 | 9 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants | 296 Participants | 152 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 15 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 26 Participants | 12 Participants |
| Race (NIH/OMB) White | 123 Participants | 259 Participants | 136 Participants |
| Region of Enrollment United States | 148 Participants | 300 Participants | 152 Participants |
| Sex: Female, Male Female | 66 Participants | 130 Participants | 64 Participants |
| Sex: Female, Male Male | 82 Participants | 170 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 33 / 148 | 37 / 152 |
| other Total, other adverse events | 0 / 148 | 0 / 152 |
| serious Total, serious adverse events | 5 / 148 | 8 / 152 |
Outcome results
Primary
Total Opioid Administered
total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
Time frame: up to 4 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine | Total Opioid Administered | 4.0 Morphine Milligram Equivalents |
| Placebo | Total Opioid Administered | 6.0 Morphine Milligram Equivalents |
Secondary
Improves Analgesia
as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Time frame: up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine | Improves Analgesia | 4.0 score on a scale |
| Placebo | Improves Analgesia | 4.0 score on a scale |
Secondary
Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation
as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.
Time frame: up to 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Participants without recorded nausea | 35 Participants |
| Dexmedetomidine | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Participants with recorded nausea | 113 Participants |
| Placebo | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Participants with recorded nausea | 110 Participants |
| Placebo | Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation | Participants without recorded nausea | 42 Participants |