Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

• Status: Recruiting
• Trial end date: 2022-09-25
• Target enrollment: 0
• Participant gender: All

Summary

pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Fentanyl; Sufentanil

Criteria

Inclusion Criteria:

• Adults aged 18-65 years;

• Scheduled for elective knee arthroscopy without anticipated ligamentous repair;

• Planned general anesthesia without a regional block or wound infiltration with local anesthesia;

• Planned day-of-surgery discharge.

Exclusion Criteria:

• Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;

• Known hypersensitivity to sufentanil or components of DSUVIA;

• Active seizure disorder;

• Increased intracranial pressure, brain tumor, head injury, or impaired consciousness;

• Severe chronic pulmonary disease;

• Severe bronchial asthma;

• Gastrointestinal obstruction;

• Hepatic or renal insufficiency;

• Adrenal insufficiency;

• Pregnancy or actively breastfeeding;

• Serotonergic drug use within 8 weeks of surgery;

• Active treatment with CYP34A inhibitors (e.g. erythromycin, clarithromycin, ketoconazole, ritonavir, etc.) or inducers (e.g. rifampin, carbamazepine, phenytoin, etc.).