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Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

NCT ID: NCT04561375

Last Updated: 2023-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2022-07-01

Brief Summary

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

Detailed Description

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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

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Knee Arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group

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

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

30 µg tablet of sublingual sufentanil

Control Group

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

Group Type PLACEBO_COMPARATOR

Fentanyl

Intervention Type DRUG

50 µg fentanyl

Interventions

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Sufentanil

30 µg tablet of sublingual sufentanil

Intervention Type DRUG

Fentanyl

50 µg fentanyl

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabry Ayad, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-642

Identifier Type: -

Identifier Source: org_study_id