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Intraoperative Fentanyl Dose on Respiratory Complications

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ClinicalTrials.gov Identifier: NCT03198208
Recruitment Status : Unknown
Verified June 2017 by Matthias Eikermann, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief Summary:
Fentanyl is the most commonly used opioid during anesthesia at Massachusetts General Hospital. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyl's pharmacokinetic properties are more problematic as the context sensitive half-time increases with duration of fentanyl infusion. This may lead to respiratory complications particularly in patients who receive fentanyl for surgical procedures of long duration. Considering the common use of fentanyl during surgery and its duration of action that is hard to predict during long surgical procedures, we will evaluate the association between intraoperative fentanyl dose and postoperative respiratory complications within 3 days of surgery.

Condition or disease Intervention/treatment
Fentanyl Opioid Use Surgery Respiratory Complication Drug: Fentanyl dose administration

Detailed Description:

Our team has conducted a series of studies to define the optimal anesthesia plan that minimizes the risk of postoperative respiratory complications. Opioids are almost always used in the perioperative management of patients undergoing surgery during anesthesia. Intraoperatively they are administered to achieve adequate surgical conditions. Opioids are respiratory depressants. They decrease dose-dependently the drive to the respiratory pump muscles and upper airway dilator muscles, which leads to respiratory acidemia and hypercapnia. Fentanyl is the most commonly used opioid during anesthesia at MGH. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyls pharmacokinetic is more problematic as the context sensitive half-life increases with duration of fentanyl administration. This may lead to respiratory complications. Considering the common use of fentanyl during surgery and its duration of action that is hard to predict during long surgical procedures, we will evaluate the association between intraoperative fentanyl dose and postoperative respiratory complications within 3 days of surgery.

To account for other factors that may affect the incidence of postoperative respiratory complications, we included the following confounder model in all of our analyses:

  • Gender
  • Age
  • BMI (body mass index)
  • ASA status classification
  • CCI (Charlson Comorbidity Index)
  • Inhalational anesthetics as MAC
  • Long lasting opioids as IV-morphine milligram equivalent including morphine, hydromorphone, methadone and sufentanil.
  • Use of neuraxial anesthesia
  • Intraoperative vasopressor dose
  • Intraoperative NMBA (neuromuscular blocking agent) dose
  • Intraoperative hypotension as number of minutes of an MAP (mean arterial pressure) <55 mmHG
  • Duration of surgery
  • Emergency status
  • Intraoperative fluids
  • PRBC (packed red blood cells) units
  • Work RVU [relative value unit]
  • Surgical service
  • Admission type (ambulatory vs inpatient)
  • SPORC (Score for Prediction of Postoperative Respiratory Complications)
  • SPOSA (Score for Prediction of Obstructive Sleep Apnea)
  • Inspiratory O2 - Fraction
  • Protective ventilation (defined as PEEP=5 and plateau pressure between 0 and 16)
  • Perioperative naloxone use
  • Prescription of any of the following opioids within 90 days prior to surgery: oxycodone, codeine, hydrocodone, buprenorphine, butorphanol, opium, hydromorphone, fentanyl, meperidine, morphine, levorphanol, methadone, nalbuphine, tapentadol, oxymorphone, roxicodone, tramadol
  • Code status (DNR)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 183396 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Effects of Intraoperative Fentanyl Dose on Postoperative Respiratory Complications
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : December 31, 2015
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Reference group
No fentanyl dose administered during surgery
Drug: Fentanyl dose administration
Comparative group
Fentanyl dose administered during surgery
Drug: Fentanyl dose administration



Primary Outcome Measures :
  1. Postoperative respiratory complications [ Time Frame: Between the day of surgery and the third day after surgery ]
    New postoperative respiratory complications occuring within 3 days after surgery


Other Outcome Measures:
  1. Post-extubation desaturation [ Time Frame: Immediately after endotracheal extubation at the end of surgery ]
    Oxygen saturation below 80% and 90% measured immediately after endotracheal extubation

  2. Non-invasive ventilation [ Time Frame: Between the day of surgery and the third day after surgery ]
    Incidence of non-invasive ventilation after surgery

  3. ICU admission rate [ Time Frame: Between day of surgery and hospital discharge, may be up to one year ]
    Admission to the ICU after surgery

  4. Hospital length of stay [ Time Frame: Number of days between day of hospital admission and hospital discharge, may be up to one year ]
    Total duration of hospitalized days

  5. Total hospital costs [ Time Frame: Between day of hospital admission and hospital discharge, may be up to one year ]
    Total costs for hospital stay

  6. Wound infection [ Time Frame: Between the day of surgery and 30 days after surgery ]
    Incidence of wound infection after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with surgeries performed between 01/2007 and 12/2015 at Massachusetts General Hospital and two affiliated community hospitals.
Criteria

Inclusion Criteria:

  • Surgical patients at Massachusetts General Hospital and two affiliated community hospitals
  • 18 years of age and older
  • Only patients who required general anesthesia with an endotracheal tube for the surgical procedure and were extubated in the operating room at the end of the procedure.

Exclusion Criteria:

  • Brain dead patients (ASA greater than 5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198208


Locations
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United States, Massachusetts
The Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthias Eikermann, Associate Professor of Anaesthesia, Harvard Medical School; Clinical Director, Critical Care Division, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03198208     History of Changes
Other Study ID Numbers: 2017P000825
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics