Intraoperative Fentanyl Dose on Respiratory Complications

Surgery Clinical Trial

Official title:

Effects of Intraoperative Fentanyl Dose on Postoperative Respiratory Complications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03198208
• Other study ID #: 2017P000825
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: June 23, 2017
• Start date: January 1, 2007
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 183396
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fentanyl
• Opioid Use
• Respiratory Complication
• Surgery

Intervention

Drug:
• Fentanyl dose administration

Locations

Country	Name	City	State
United States	The Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

de Jong MA, Ladha KS, 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):362-9. doi: 10.1097/SLA.0000000000001499. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thevathasan T, Shih S, Safavi KC, Berger DL, Burns SM, Grabitz SD, Glidden, RS, Zafonte RD, Eikermann M, Schneider JC. Dose-dependent association between intraoperative non-depolarising neuromuscular blocking agent dose and 30-day readmission following abdominal surgery. Br J Anaesth. 2017 Ahead of print.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-extubation desaturation	Oxygen saturation below 80% and 90% measured immediately after endotracheal extubation	Immediately after endotracheal extubation at the end of surgery
Other	Non-invasive ventilation	Incidence of non-invasive ventilation after surgery	Between the day of surgery and the third day after surgery
Other	ICU admission rate	Admission to the ICU after surgery	Between day of surgery and hospital discharge, may be up to one year
Other	Hospital length of stay	Total duration of hospitalized days	Number of days between day of hospital admission and hospital discharge, may be up to one year
Other	Total hospital costs	Total costs for hospital stay	Between day of hospital admission and hospital discharge, may be up to one year
Other	Wound infection	Incidence of wound infection after surgery	Between the day of surgery and 30 days after surgery
Primary	Postoperative respiratory complications	New postoperative respiratory complications occuring within 3 days after surgery	Between the day of surgery and the third day after surgery