Predictors of Opioid-Induced Respiratory Depression (OIRD)

NCT02473354 | Completed Phase 1

• 1 other identifier: Pro00060429
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic conditions. (2) Measurement of specific respiratory parameters to predict the opioid-induced respiratory depression (OIRD) response.

Conditions

Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Hypercapnic Ventilatory Response (HCVR) gradient based upon ETCO2 and Minute Volume

  Is there a correlation between the HCVR and susceptibility of OIRD.

  Sequence #1 approximately 30 minutes

Secondary Outcomes (1)

• The proportion of subjects who are classified as low, medium, or high risk for Opioid Induced Respiratory Depression (OIRD).

  Sequence #2 approximately 1 hour

Study Arms (1)

Resp Depression Sequence 1 - 3

OTHER

Sequence #1: breathe 21% through the facemask and increase ventilation to achieve a target hypocapnic ET CO2 of 25 - 30 mmHg. Subject will then breathe a gas mixture containing 6% CO2 / 30% O2 to achieve a target hypercapnic ET CO2 up to 60 mmHg or HCVR is terminated at the discretion of the PI. Sequence #2: breathe 21% O2 (normoxia) before remifentanil administration Sequence #3: breathe 50% O2 (hyperoxia) before remifentanil administration

Drug: Remifentanil; Drug: Oxygen; Drug: Carbon dioxide

Interventions

Remifentanil DRUG

The opioid used for this study is Remifentanil and is commonly used in the operating room. Remifentanil will be given under normoxic (breathing room air \[21% Oxygen\]) and hyperoxic (breathing 50% oxygen) conditions to determine if the measurement of the specific respiratory parameters will predict the OIRD response.

Resp Depression Sequence 1 - 3

Oxygen DRUG

Remifentanil will be administered under normal oxygen (normoxia) and increased oxygen (hyperemic) conditions.

Also known as: O2

Resp Depression Sequence 1 - 3

Carbon dioxide DRUG

Carbon dioxide is used as part of the hypercapnia ventilatory response measurement (HCVR)

Also known as: CO2

Resp Depression Sequence 1 - 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• is between 18 and 50 years of age;
• weighs greater than 40 kilograms;
• is American Society Anesthesiologist (ASA) status 1 \[assessment by PI or delegate\];
• has a BMI between 18.0 and 30.0 \[calculated from measured height \& weight\];
• has completed the appropriate fasting periods for solids and liquids prior to the administration of remifentanil
• and has provided written informed consent and is willing to comply with the study procedures.

You may not qualify if:

• has a prior or known allergy to lidocaine or similar pharmacologic agents;
• is currently taking any medication other than for birth control;
• is currently participating in, or has recently participated in (discontinued within 30 days prior to this study) in an investigational drug study \[self-reported\];
• has a negative Allen's Test to confirm patency of the collateral artery \[clinical assessment by PI or delegate\];
• has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
• is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure;
• has anemia \[measured by venous blood gas sample\];
• has a history of sickle cell disease \[self-reported\];
• has a positive urine cotinine or urine drug screen or oral ethanol test \[POC testing\];
• has a history of narcotic or recreational drug addition \[self reported by subject in response to questioning by PI or delegate; review of duke electronic medical history record\];
• has room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\];
• has a clinically significant abnormal EKG \[assessment by PI or delegate\];
• has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
• has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\];
• is intolerant to a breathing mask apparatus \[assessment by PI or delegate\];

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Remifentanil; Oxygen; Carbon Dioxide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chalcogens; Elements; Inorganic Chemicals; Gases; Carbon Compounds, Inorganic; Oxides; Oxygen Compounds

Study Officials

• David MacLeod, MB BS

  Duke Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 16, 2015
• Study Start: April 1, 2015
• Primary Completion: April 29, 2018
• Study Completion: April 29, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

US (1)