Respiratory Control and Narcotic Effects

NCT04047550 | Completed FDA Device

• 1 other identifier: Pro00046973
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to provide data that will assess the role of ventilatory chemosensitivity (respiratory drive) in determining postoperative respiratory depression due to opioids. In a group of patients requiring surgery and admission to hospital, before surgery, ventilatory chemosensitivity will be assessed in the presence or absence of an infusion of remifentanil. Parameters will be correlated with ventilatory depression events after surgery. A secondary aim is to determine whether respiratory depression is more likely during specific phases of sleep.

Conditions

Ventilatory Depression; Opioid Intoxication; Opioid Toxicity

Outcome Measures

Primary Outcomes (1)

• Opioid related respiratory depression (OIRD) frequency

  A respiratory event is defined as one or more of the following: 1. Respiratory rate \<60% of baseline 2. Minute ventilation (MV) \<60% of predicted value based on body surface area (BSA). Predicted MV for men=4 x BSA, for women=3.5 x BSA 3. Pulse oximeter reading (SpO2) \<90% (breathing room air) or \<92% (breathing supplemental O2) 4. Transcutaneous PCO2 \>50 mmHg 5. Central or obstructive apnea/hypopnea detected by WatchPAT (Itamar Medical, Atlanta, GA) based on decrease in peripheral arterial tone amplitude, increase in heart rate and decrease in SpO2 ≥3% or snoring in the absence of body movement. Events must last 1 minute or more to be counted. Events occurring within one minute of each are combined as a single event.

  From the arrival of the patient in the post anesthesia care unit until the first postoperative morning

Secondary Outcomes (1)

• Frequency of OIRD during specific sleep stages

  From the arrival of the patient in the post anesthesia care unit until the first postoperative morning

Interventions

Ventilatory chemosensitivity DIAGNOSTIC_TEST

Using this technique, the patient first voluntarily hyperventilates to a PETCO2 value of 20-25 mmHg, then undergoes a rebreathing test allowing the PCO2 to rise to 55-60 mmHg while PETO2 is maintained at 150 mmHg. The procedure is then repeated with PETO2 clamped at 50 mmHg. Parameters derived from this method include slopes of the ventilatory response during hyperoxia and hypoxia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery requiring opioids for postoperative analgesia

You may qualify if:

• years of age or older, undergoing major abdominal or urological surgery requiring at least one overnight hospital stay

You may not qualify if:

• Pregnancy Adverse reaction to remifentanil Opioid-use within the past month Dependency on supplemental oxygen Brain injury in the past year Coronary artery disease Sickle cell disease.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Richard E Moon, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 6, 2019
• Study Start: March 8, 2018
• Primary Completion: February 9, 2019
• Study Completion: February 9, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)