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NCT Number: NCT03201315

The Incremental Risk of Intraoperative Fentanyl on PONV

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy Hospital Basel

Basel, 4031, Switzerland

About this study

The primary aims of this quality control study are:

  • 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
  • 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:

  • receiver operating characteristic (ROC) curves of the logistic model without fentanyl, with fentanyl (continuous), and with fentanyl (categorical).
  • 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
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery

    Time frame: within 24 hours (or next morning discharge)

    postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) within 24 hours (or next morning discharge)

Secondary outcomes

  1. number of postoperative vomiting events within 24 hours

    Time frame: within 24 hours (or next morning discharge)

    Number of times vomiting (0, 1-2, >3 times; either by chart or by patient confirmation) within 24 hours (or next morning discharge)

  2. Any postoperative nausea and/or vomiting (PONV) while in the recovery room

    Time frame: first two postoperative hours

    Postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) while in recovery room

  3. Worst pain, i.e. highest Numeric Rating Score (NRS)

    Time frame: within 24 hours / in recovery room (first two postoperative hours)

    highest / worst pain score within 24 hours / in recovery room (defined as above)

Other outcomes

  1. Dose of postoperative administration of opioids

    Time frame: within 24 hours / in recovery room (first two postoperative hours)

    quantification of postoperative administration of opioids 24 hours/recovery room

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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