NCT04561375

Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Arthroscopy

Interventions

Type	Name	Description
DRUG	Sufentanil	30 µg tablet of sublingual sufentanil
DRUG	Fentanyl	50 µg fentanyl

Timeline

• Start date: 2020-12-11
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-09-23
• Last updated: 2023-12-13
• Results posted: 2023-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study