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

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

Study Overview

• Status: Terminated
• Conditions: Knee Arthroscopy
• Intervention / Treatment: Drug: Sufentanil; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sabry Ayad, MD; Phone Number: 216-476-2275; Email: Saayad@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.	Drug: Sufentanil; 30 µg tablet of sublingual sufentanil
Placebo Comparator: Control Group; placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia	Drug: Fentanyl; 50 µg fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Consumption of Fentanyl	The total amount of fentanyl consumed in PACU.	About 3 hours in PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Recovery Time	Recovery will be considered complete at the time an order is placed for progression to phase II.	1.5 hours
Time to Fitness for PACU Discharge	This will be determined per facility protocol-scheduled assessments using the CCF Phase II Discharge Scoring tool. The time that the minimum acceptable score of 14 is achieved will be recorded	1 - 2 hours.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Consumption of Fentanyl in PACU	The total amount of fentanyl consumed in PACU.	About 3 hours in PACU

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Sabry Ayad, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Sufentanil
• Other Study ID Numbers: 20-642

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes