The Incremental Risk of Intraoperative Fentanyl on PONV

The Incremental Risk of Intraoperative Fentanyl on PONV: A Modifiable Risk Without Drawbacks?

The aim of this quality control study is to describe the presence and intensity of postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl dosing. Additionally, the investigators will examine pain scores.

Study Overview

• Status: Completed
• Conditions: PONV

Detailed Description

The primary aims of this quality control study are:

1. to determine whether there is an independent association between the intraoperative administration of fentanyl (both as a continuous and categorical variable) and PONV within 24 postoperative hours
2. determine whether or not the intraoperative fentanyl amount can be used to successfully restratify patients for PONV beyond the simplified Apfel score for PONV

All required data is collected in regular daily practice. The following variables will be assessed by univariable models:

Preoperative variables (e.g. patient characteristics) Surgical/Anesthesia variables (e.g. type/length of surgery, antiemetics) Outcome variables (PONV, worst pain as delineated in the outcomes section), Intraoperative fentanyl measured 1) as a continuous variable and 2) by predefined limits of 0 to 0.2mg, >0.2-0.5mg, >0.5 to 0.8mg, and >8mg.

Finally for the multivariable model, the investigators will adjust for confounders, specifically for sex (m/f), history (Hx) of PONV (y/n), Hx of motion sickness (y/n), current smoker (y/n), age (years), expected duration of surgery (min; >60 min), postoperative opioids (y/n), the use of preemptive PONV Therapy (0,1,2 medications), propofol vs. inhalative agents (y/n), and surgery type (3 kinds) from the patient's electronic record. In the event that insufficient event rates are observed, we will collapse the variables into the simplified Apfel score to assess the independent value of fentanyl in predicting PONV.

In addition to a logistic model as delineated above, we will conduct the following:

1. receiver operating characteristic (ROC) curves of the logistic model without fentanyl, with fentanyl (continuous), and with fentanyl (categorical).
2. additionally, ROCs of a simplified model using the Apfel score, the Apfel score with fentanyl (continous), and the Apfel score with fentanyl (categorical) will be made. Comparison of area under the receiver operating characteristics(AUROCs) by DeLong
3. net reclassification improvement (NRI) of both the logistic model with and without fentanyl as well as the Apfel score with and without fentanyl

To assess pain and administered fentanyl, we will examine pain scores by the numeric rating scale (NRS).

• Study Type: Observational
• Enrollment (Actual): 363

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitiy Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an elevated PONV risk undergoing abdominal, gynecological, or otorhinolaryngological in-patient surgery

Description

Inclusion Criteria:

• In-patients with an expected simplified Apfel score of 2 or higher,
• Aged >= 18 years, and
• Undergoing general anesthesia (with or without neuraxial or regional anesthesia.)
• in abdominal, gynecological or otorhinolaryngological surgery

Exclusion Criteria:

• Outpatients
• Patients with chronic pain, defined as recurring pain requiring intermittent hospitalization or regular intake of pain medication.
• Non-opioid naïve patients, defined as a history of abuse or having taken opioids within the last 30 days

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery	postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) within 24 hours (or next morning discharge)	within 24 hours (or next morning discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of postoperative vomiting events within 24 hours	Number of times vomiting (0, 1-2, >3 times; either by chart or by patient confirmation) within 24 hours (or next morning discharge)	within 24 hours (or next morning discharge)
Any postoperative nausea and/or vomiting (PONV) while in the recovery room	Postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) while in recovery room	first two postoperative hours
Worst pain, i.e. highest Numeric Rating Score (NRS)	highest / worst pain score within 24 hours / in recovery room (defined as above)	within 24 hours / in recovery room (first two postoperative hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of postoperative administration of opioids	quantification of postoperative administration of opioids 24 hours/recovery room	within 24 hours / in recovery room (first two postoperative hours)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Oliver Bandschapp, PD Dr., University Hospital, Basel, Switzerland; Principal Investigator: Wilhelm Ruppen, PD Dr., University Hospital, Basel, Switzerland; Principal Investigator: Eckhard Mauermann, MD, MSc, University Hospital Basel; University Hospital Ghent

Publications and helpful links

General Publications

• Mauermann E, Clamer D, Ruppen W, Bandschapp O. Association between intra-operative fentanyl dosing and postoperative nausea/vomiting and pain: A prospective cohort study. Eur J Anaesthesiol. 2019 Nov;36(11):871-880. doi: 10.1097/EJA.0000000000001081.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Fentanyl, opioids
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting
• Other Study ID Numbers: EKNZ 2016-01605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No