Post-operative Pain, Respiratory Depression
Conditions
Keywords
Dexmedetomidine, Sedation, Opioid, Respiratory depression
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine titrated over 24 hours
OTHERPlacebo (Normal Saline)
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) class I, II or III * Undergoing thoracic surgery on an inpatient basis * Age 18 up to 85 years of age
Exclusion criteria
* Subject is pregnant and/or lactating * Subject has a serious Central Nervous System (CNS)pathology/trauma that, per clinical judgment of the investigator, precludes responsiveness or survival. * Subject for whom alpha-2 agonists are contraindicated * Subject meets any of the following cardiovascular criteria: * Acute unstable angina (defined during current hospital stay) * Suspicion of acute myocardial infarction. * Considered to have a left ventricular ejection fraction of less than 30%.Decision to exclude is predicated in the Investigator's opinion, and may be based on any combination of acute presentations, recently preformed diagnostic studies, or a history that suggests poor cardiac function. Pulmonary congestion of a non-cardiac origin or mild congestive failure primarily attributable to etiologies other than poor ventricular function are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | An average of 24 hours, up to 30 hours per patient | To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the Amount of Respiratory Depression in Each Groups | Hours 6 to 16 | Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours. |
Countries
United States
Participant flow
Recruitment details
Participants will be recruited from the from the BUMC Operating Room schedule prior to their procedure. Informed consent will be obtained in a secure area. Recruitment will continue until goal reached.
Pre-assignment details
Participants were required to be between the ages of 18-85 and receiving general anesthesia with an AMerican Society of Anesthesiologists score of three or less, and undergoing thoracotomy surgery. Liver and renal failure patients were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline Standard of care | 19 |
| Dexmedetomidine titrated IV for 24 hours post ICU | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 10.75 | 58 years STANDARD_DEVIATION 12.8 | 60 years STANDARD_DEVIATION 11.75 |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 19 | 5 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.
To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.
Time frame: An average of 24 hours, up to 30 hours per patient
Population: Participants completing the study were analyzed as per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | Morphine equivalency administered | 49 IV morphine equivalency in mg |
| Placebo | Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | Adjusted for total time on study drug | 54 IV morphine equivalency in mg |
| Dexmedetomidine | Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | Morphine equivalency administered | 29 IV morphine equivalency in mg |
| Dexmedetomidine | Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. | Adjusted for total time on study drug | 35 IV morphine equivalency in mg |
p-value: 0.03t-test, 2 sided
p-value: 0.04t-test, 2 sided
Secondary
Measure the Amount of Respiratory Depression in Each Groups
Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.
Time frame: Hours 6 to 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Measure the Amount of Respiratory Depression in Each Groups | 45 mmHg | Standard Deviation 9 |
| Dexmedetomidine | Measure the Amount of Respiratory Depression in Each Groups | 42 mmHg | Standard Deviation 8 |
Comparison: The p-value reported in this table corresponds with the 6 to 16 hour time frame.p-value: 0.02t-test, 2 sided