Intraoperative Fentanyl Dose on Respiratory Complications

NCT03198208 | Unknown

• 1 other identifier: 2017P000825
• Study Type: observational
• Target: 183,396
• Locations: 1 country
• Sites: 1

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.

Conditions

Fentanyl; Opioid Use; Surgery; Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• Postoperative respiratory complications

  New postoperative respiratory complications occuring within 3 days after surgery

  Between the day of surgery and the third day after surgery

Other Outcomes (6)

• Post-extubation desaturation

  Immediately after endotracheal extubation at the end of surgery

• Non-invasive ventilation

  Between the day of surgery and the third day after surgery

• ICU admission rate

  Between day of surgery and hospital discharge, may be up to one year

Study Arms (2)

Reference group

No fentanyl dose administered during surgery

Drug: Fentanyl dose administration

Comparative group

Fentanyl dose administered during surgery

Drug: Fentanyl dose administration

Interventions

Fentanyl dose administration DRUG

Comparative group; Reference group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Surgical patients at Massachusetts General Hospital and two affiliated community hospitals
• 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.

You may not qualify if:

• Brain dead patients (ASA greater than 5)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

The Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• 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.

  PMID: 28323670 BACKGROUND

• 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.

  PMID: 29121289 BACKGROUND

• 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.

  PMID: 26496082 BACKGROUND

• 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.

  PMID: 26174419 BACKGROUND

• 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.

  PMID: 28558716 BACKGROUND

• 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.

  PMID: 23571640 BACKGROUND

• Friedrich S, Raub D, Teja BJ, Neves SE, Thevathasan T, Houle TT, Eikermann M. Effects of low-dose intraoperative fentanyl on postoperative respiratory complication rate: a pre-specified, retrospective analysis. Br J Anaesth. 2019 Jun;122(6):e180-e188. doi: 10.1016/j.bja.2019.03.017. Epub 2019 Apr 11.

  PMID: 30982564 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia, Harvard Medical School; Clinical Director, Critical Care Division

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 26, 2017
• Study Start: January 1, 2007
• Primary Completion: December 31, 2015
• Study Completion: June 30, 2018
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)