Brief Summary
In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.
Brief Title
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Pain
Eligibility Criteria
Inclusion Criteria:
* Age range 18-100 years
* Currently taking Suboxone
* ASA (American Society of Anesthesiology) physical score 1-3
* Able to provide a signed informed consent
* General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
Exclusion Criteria:
* Known allergic reactions to Dsuvia and its excipients
* Severe respiratory illness including exacerbation of asthma attack
* Significant intraoperative hemodynamic instability
* Use of Regional anesthesia techniques
* Age range 18-100 years
* Currently taking Suboxone
* ASA (American Society of Anesthesiology) physical score 1-3
* Able to provide a signed informed consent
* General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
Exclusion Criteria:
* Known allergic reactions to Dsuvia and its excipients
* Severe respiratory illness including exacerbation of asthma attack
* Significant intraoperative hemodynamic instability
* Use of Regional anesthesia techniques
Inclusion Criteria
Inclusion Criteria:
* Age range 18-100 years
* Currently taking Suboxone
* ASA (American Society of Anesthesiology) physical score 1-3
* Able to provide a signed informed consent
* General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
* Age range 18-100 years
* Currently taking Suboxone
* ASA (American Society of Anesthesiology) physical score 1-3
* Able to provide a signed informed consent
* General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT04716413
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12649
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series
Primary Outcomes
Outcome Description
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
Outcome Measure
Morphine Equivalence
Outcome Time Frame
During day of surgery
Secondary Outcomes
Outcome Description
How much time did subject take to become considered 'fit to discharge?'
Outcome Time Frame
During stay in PACU, up until discharge from PACU
Outcome Measure
Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)
Outcome Description
A measure of how any additional opioids subjects were administered
Outcome Time Frame
PACU stay to 24 hours post hospital discharge
Outcome Measure
Need for Additional Opioids Following Surgery
Outcome Description
Average time for administration of first additional opioid.
Outcome Time Frame
24 hours post hospital discharge
Outcome Measure
Time to Take the First Additional Opioid
Outcome Description
Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU
Outcome Time Frame
During PACU stay, up until discharge from PACU
Outcome Measure
Adverse Events in the PACU
Outcome Description
Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
Outcome Time Frame
24 hours
Outcome Measure
Adverse Events Post Discharge From PACU
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Naum Shaparin
Investigator Email
nshapari@montefiore.org