Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

NCT04561375 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-642
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Total Consumption of Fentanyl

  The total amount of fentanyl consumed in PACU.

  About 3 hours in PACU

Secondary Outcomes (2)

• Phase 1 Recovery Time

  1.5 hours

• Time to Fitness for PACU Discharge

  1 - 2 hours.

Other Outcomes (1)

• Total Consumption of Fentanyl in PACU

  About 3 hours in PACU

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.

Drug: Sufentanil

Control Group

PLACEBO COMPARATOR

placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia

Drug: Fentanyl

Interventions

Sufentanil DRUG

30 µg tablet of sublingual sufentanil

Intervention Group

Fentanyl DRUG

50 µg fentanyl

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

MeSH Terms

Interventions

Sufentanil; Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Daniel Sessler
• Organization: Cleveland Clinic

ds@ccf.org

2168702620

Study Officials

• Sabry Ayad, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 23, 2020
• Study Start: December 11, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-12

Locations

US (1)