Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil

NCT04959812 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STU-2021-0579
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Tolerance to Simulated Hemorrhage

  Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and sufentanil limbs, by causing progressive central hypovolemia via lower-body negative pressure. This progressive lower-body negative pressure (LBNP) challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc).

  6 hours

Secondary Outcomes (1)

• Pain Assessment

  6 hours

Study Arms (2)

Sufentanil

EXPERIMENTAL

Sufentanil (30 microgram tablet) will be administered via a sublingual pill

Drug: Sufentanil

Placebo

PLACEBO COMPARATOR

Placebo will be administered via a sublingual pill

Other: Placebo

Interventions

Sufentanil DRUG

Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Sufentanil

Placebo OTHER

Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
• Speak English

You may not qualify if:

• Subjects not in the defined age range
• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Body mass less than 65 kg
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Subjects who cannot speak or read English
• Positive urine drug screen
• Currently taking pain modifying medication(s)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Craig Crandall
• Organization: University of Texas Southwestern Medical Center

CraigCrandall@texashealth.org

214-345-4623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 13, 2021
• Study Start: March 1, 2022
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: June 26, 2025
• Results First Posted: July 11, 2024

Record last verified: 2025-06

Locations

US (2)