Skip to content

Intraoperative Fentanyl Dose on Respiratory Complications

Effects of Intraoperative Fentanyl Dose on Postoperative Respiratory Complications

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03198208
Enrollment
183396
Registered
2017-06-26
Start date
2007-01-01
Completion date
2018-06-30
Last updated
2017-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fentanyl, Opioid Use, Respiratory Complication, Surgery

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.

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)

Interventions

DRUGFentanyl dose administration

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative respiratory complicationsBetween the day of surgery and the third day after surgeryNew postoperative respiratory complications occuring within 3 days after surgery

Other

MeasureTime frameDescription
Non-invasive ventilationBetween the day of surgery and the third day after surgeryIncidence of non-invasive ventilation after surgery
ICU admission rateBetween day of surgery and hospital discharge, may be up to one yearAdmission to the ICU after surgery
Post-extubation desaturationImmediately after endotracheal extubation at the end of surgeryOxygen saturation below 80% and 90% measured immediately after endotracheal extubation
Total hospital costsBetween day of hospital admission and hospital discharge, may be up to one yearTotal costs for hospital stay
Wound infectionBetween the day of surgery and 30 days after surgeryIncidence of wound infection after surgery
Hospital length of stayNumber of days between day of hospital admission and hospital discharge, may be up to one yearTotal duration of hospitalized days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026