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Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

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ClinicalTrials.gov Identifier: NCT04561375
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Knee Arthroscopy Drug: Sufentanil Drug: Fentanyl Phase 4

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) pain; 2) time to first request for analgesia; and, 3) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : September 25, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Total consumption of fentanyl [ Time Frame: 3 hours ]
    The total amount of fentanyl consumed after surgery.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 2 hours. ]
    The pain score will be measured as 0-10 Verbal Response Scores conducted at rest. O meaning no pain, and 10 being the worst pain.

  2. Postoperative Nausea and Vomiting [ Time Frame: 2 hours. ]
    The investigator will use the (PONV) Intensity Scale, at intervals will be used, for postoperative nausea and vomiting.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561375


Contacts
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Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
Contact: Sabry Ayad, MD 216-476-2275 Saayad@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Sabry Ayad, MD    216-476-2245    Saayad@ccf.org   
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Principal Investigator: Sabry Ayad, MD         
Sponsors and Collaborators
The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04561375    
Other Study ID Numbers: 20-642
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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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
Additional relevant MeSH terms:
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Fentanyl
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics