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Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04561375
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
36.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Sep 4, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Sep 25, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Total consumption of fentanyl [3 hours]

    The total amount of fentanyl consumed after surgery.

Secondary Outcome Measures

  1. Pain Score [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 [2 hours.]

    The investigator will use the (PONV) Intensity Scale, at intervals will be used, for postoperative nausea and vomiting.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Cleveland Clinic Fairview Hospital Cleveland Ohio United States 44111

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT04561375
Other Study ID Numbers:
  • 20-642
First Posted:
Sep 23, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
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:
Fentanyl
Sufentanil

Study Results

No Results Posted as of Mar 25, 2022