Remifentanil in Adults With OSA

NCT02898792 | Completed Early Phase 1

• 1 other identifier: 201605158
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive Sleep Apnea (OSA) is the most common problem that affects sleep. People with this problem have their airway blocked or minimized, causing snoring or gasping while sleeping. It can also reduce the amount of oxygen that circulates in the blood of people affected by it. Millions of Americans have OSA; 10% of adults have diagnosed OSA, an estimated 25% have undiagnosed OSA. There is concern in the medical community about how to manage pain in patients with OSA because of the risk of decreased or slower breathing associated with certain pain medications called opioids. Giving OSA patients opioids could cause them to have even lower oxygen amounts in their blood stream. It is conceivable that patients with OSA may require lower doses of opioids to cause decreased breathing as compared to patients without OSA, however this has not been proven. In this study, we are using a very short acting and easily reversible opioid pain medication called remifentanil in patients with OSA in order to find out if treated and untreated OSA patients respond to opioid differently than patients without OSA.

Conditions

Apnea, Sleep

Keywords

sensitivity, opioid

Outcome Measures

Primary Outcomes (1)

• The relationship between remifentanil concentration and miotic effect

  Baseline, 10, 20, 30, 40, and 50 minutes for each concentration

Study Arms (3)

targeted infusion of remifentanil untreated OSA

EXPERIMENTAL

Stepped-dose, targeted infusion of remifentanil with measurement of miosis, respiratory rate, end-expired CO2, and thermal analgesia and plasma drug concentrations. Remifentanil dose will be based on ideal body weight.

Drug: Targeted infusion of remifentanil

targeted infusion of remifentanil CPAP treated OSA

EXPERIMENTAL

Stepped-dose, targeted infusion of remifentanil with measurement of miosis, respiratory rate, end-expired CO2, and thermal analgesia and plasma drug concentrations. Remifentanil dose will be based on ideal body weight.

Drug: Targeted infusion of remifentanil

targeted infusion of remifentanil No OSA

EXPERIMENTAL

Stepped-dose, targeted infusion of remifentanil with measurement of miosis, respiratory rate, end-expired CO2, and thermal analgesia and plasma drug concentrations. Remifentanil dose will be based on ideal body weight.

Drug: Targeted infusion of remifentanil

Interventions

Targeted infusion of remifentanil DRUG

Remifentanil dosing will be calculated using ideal body weight and infused to achieve brain concentrations of 0.5, 1, 2, 3, and 4 ng/ml; approximately 10 minutes at each concentration.

Also known as: Ultiva

targeted infusion of remifentanil CPAP treated OSA; targeted infusion of remifentanil No OSA; targeted infusion of remifentanil untreated OSA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 year-old males or non-pregnant females
• Provide informed consent

You may not qualify if:

• History of liver disease
• pregnant or nursing females
• known history of addiction to drugs or alcohol
• craniofacial anomalies that preclude proper fit of pupillometry goggles
• eye abnormalities that preclude the measurement of pupil diameter
• use of home oxygen

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Maharaj AR, Montana MC, Hornik CP, Kharasch ED. Opioid use in treated and untreated obstructive sleep apnoea: remifentanil pharmacokinetics and pharmacodynamics in adult volunteers. Br J Anaesth. 2025 Mar;134(3):681-692. doi: 10.1016/j.bja.2024.10.042. Epub 2025 Jan 20.

  PMID: 39837697 DERIVED

• Montana MC, McLeland M, Fisher M, Juriga L, Ercole PM, Kharasch ED. Opioid sensitivity in treated and untreated obstructive sleep apnoea: a prospective cohort study. Br J Anaesth. 2024 Jan;132(1):145-153. doi: 10.1016/j.bja.2023.09.032. Epub 2023 Nov 7.

  PMID: 37945413 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypersensitivity

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Evan Kharasch, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: September 16, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)