A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- The Cleveland Clinic
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Total Consumption of Fentanyl
Study Overview
Brief Summary
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.
Detailed Description
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery. The results will help us estimate treatment effect and determine sample size for a subsequent full-scale clinical trial.
Primary Endpoint: total amount of fentanyl consumed during hospital admission. Secondary Endpoints: 1) phase I recovery time; and, 2) time to fitness for discharge.
Exploratory Endpoints: 1) intraoperative hemodynamics; 2) intraoperative opioid use; 3) intraoperative sevoflurane use; 4) postoperative pain; 5) postoperative sedation and cognitive recovery 6) time to first request for analgesia; and, 7) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older;
- •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;
- •Patients with an allergy or hypersensitivity to opioids;
- •Pregnancy or actively breastfeeding;
- •Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
- •Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
Arms & Interventions
Intervention Group
30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.
Intervention: Sufentanil (Drug)
Control Group
placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia
Intervention: Fentanyl (Drug)
Outcomes
Primary Outcomes
Total Consumption of Fentanyl
Time Frame: About 3 hours in PACU
The total amount of fentanyl consumed in PACU.
Secondary Outcomes
- Phase 1 Recovery Time(1.5 hours)
- Time to Fitness for PACU Discharge(1 - 2 hours.)