Intraoperative Fentanyl Dose on Respiratory Complications
Study Details
Study Description
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 | Phase |
|---|---|---|
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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:
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Gender
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Age
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BMI (body mass index)
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ASA status classification
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CCI (Charlson Comorbidity Index)
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Inhalational anesthetics as MAC
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Long lasting opioids as IV-morphine milligram equivalent including morphine, hydromorphone, methadone and sufentanil.
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Use of neuraxial anesthesia
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Intraoperative vasopressor dose
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Intraoperative NMBA (neuromuscular blocking agent) dose
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Intraoperative hypotension as number of minutes of an MAP (mean arterial pressure) <55 mmHG
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Duration of surgery
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Emergency status
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Intraoperative fluids
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PRBC (packed red blood cells) units
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Work RVU [relative value unit]
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Surgical service
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Admission type (ambulatory vs inpatient)
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SPORC (Score for Prediction of Postoperative Respiratory Complications)
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SPOSA (Score for Prediction of Obstructive Sleep Apnea)
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Inspiratory O2 - Fraction
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Protective ventilation (defined as PEEP=5 and plateau pressure between 0 and 16)
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Perioperative naloxone use
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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
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Code status (DNR)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Reference group No fentanyl dose administered during surgery |
Drug: Fentanyl dose administration
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| Comparative group Fentanyl dose administered during surgery |
Drug: Fentanyl dose administration
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Outcome Measures
Primary Outcome Measures
- Postoperative respiratory complications [Between the day of surgery and the third day after surgery]
New postoperative respiratory complications occuring within 3 days after surgery
Other Outcome Measures
- Post-extubation desaturation [Immediately after endotracheal extubation at the end of surgery]
Oxygen saturation below 80% and 90% measured immediately after endotracheal extubation
- Non-invasive ventilation [Between the day of surgery and the third day after surgery]
Incidence of non-invasive ventilation after surgery
- ICU admission rate [Between day of surgery and hospital discharge, may be up to one year]
Admission to the ICU after surgery
- Hospital length of stay [Number of days between day of hospital admission and hospital discharge, may be up to one year]
Total duration of hospitalized days
- Total hospital costs [Between day of hospital admission and hospital discharge, may be up to one year]
Total costs for hospital stay
- Wound infection [Between the day of surgery and 30 days after surgery]
Incidence of wound infection after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Surgical patients at Massachusetts General Hospital and two affiliated community hospitals
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18 years of age and older
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
- de Jong MAC, Ladha KS, Vidal Melo MF, Staehr-Rye AK, Bittner EA, Kurth T, Eikermann M. Differential Effects of Intraoperative Positive End-expiratory Pressure (PEEP) on Respiratory Outcome in Major Abdominal Surgery Versus Craniotomy. Ann Surg. 2016 Aug;264(2):362-369. doi: 10.1097/SLA.0000000000001499.
- Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.
- Ruscic KJ, Grabitz SD, Rudolph MI, Eikermann M. Prevention of respiratory complications of the surgical patient: actionable plan for continued process improvement. Curr Opin Anaesthesiol. 2017 Jun;30(3):399-408. doi: 10.1097/ACO.0000000000000465. Review.
- Shin CH, Grabitz SD, Timm FP, Mueller N, Chhangani K, Ladha K, Devine S, Kurth T, Eikermann M. Development and validation of a Score for Preoperative Prediction of Obstructive Sleep Apnea (SPOSA) and its perioperative outcomes. BMC Anesthesiol. 2017 May 30;17(1):71. doi: 10.1186/s12871-017-0361-z.
- Thevathasan T, Shih SL, Safavi KC, Berger DL, Burns SM, Grabitz SD, Glidden RS, Zafonte RD, Eikermann M, Schneider JC. Association between intraoperative non-depolarising neuromuscular blocking agent dose and 30-day readmission after abdominal surgery. Br J Anaesth. 2017 Oct 1;119(4):595-605. doi: 10.1093/bja/aex240.
- 2017P000825